Quality Technician IV, Boston Scientific, Spencer, IN
Job ID: 26228
Position Title: Quality Technician IV
Company Name: Boston Scientific
Location(s): Spencer, IN , United States
Job Description
PURPOSE:
Assists quality engineer in support of the appropriate engineering
group, manufacturing, system/services support and materials group.
Serves as a Quality representative to improve awareness, visibility,
and communication on quality initiatives to support departmental,
functional, site, divisional and corporate quality goals and priorities.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Assist Quality Engineers in the following activities:
• Process validation
• Design verification/validation
• Product documentation
• Statistical Process Control
• Product inspection and testing
• Qualitative and/or Quantitative data analysis
• Continuous Improvement projects
• CAPA
Must comply with requirements of ISO 14001 and BSC Environmental,
Health and Safety standards and follow procedures and instructions
related to these standards.
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
SUPERVISORY RESPONSIBILITIES: None
QUALIFICATION REQUIREMENTS: To perform this job successfully, an
individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge,
skill, and/or ability required. Reasonable accommodations may be made
to enable individuals with disabilities to perform the essential
functions.
MINIMUM REQUIREMENTS: To be considered for this position you must have
the following qualifications:
EDUCATION, EXPERIENCE, and/or SKILLS
Associate’s degree in technical discipline (or equivalent).
A minimum of four years experience in a quality/manufacturing related environment.
Understanding/reading of blueprints and process flowcharting.
MicroSoft Office computer software applications literacy.
Demonstrated, working knowledge of basic STATISTICS.
Solid background in Quality Methods and Tools (including mechanical inspection).
Solid knowledge in mechanical inspection tools such as caliper, micrometer, pin gauge usage.
Demonstrated ability to comprehend and execute intricate instructions.
Reading and executing protocols for process /product validations.
Ability to use lab test equipments such as Instron force gauge, vision
system and environment conditioning chamber, etc.
Good oral and written communication abilities.
Strong attention to detail.
Team oriented individual.
PREFERRED REQUIREMENTS: The following are qualifications that we would prefer candidates to have.
Associate’s degree in technical discipline (or equivalent).
Risk analysis (FMEA) and root cause analysis techniques.
A strong knowledge of GMPs,
Ethics in the workplace and Inspection Methods and techniques.
Please mention Number Crunchers' Web Center when you apply. Thanks for your support!
Quality Engineer I, Boston Scientific, Spencer, IN
Quality Engineer I
Requisition ID 26211
Full/Part Time
Location Spencer, IN
Job Description
PURPOSE:
Provides focused quality engineering support within appropriate
engineering group, manufacturing, system/services support and the
materials group. Develops, establishes and maintains quality
engineering metrologies, systems, and practices which meet BSC,
customer, and regulatory requirements. Serves as a Quality
representative to improve awareness, visibility, communication on
quality initiatives to support departmental, functional, site,
divisional and corporate quality goals and priorities. Provides focused
quality engineering support within operational and system/service
support for the Urology business unit and other areas.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• Develops, coordinates and conducts technical reliability studies
and evaluations of engineering design concepts and design of
experiments (DOE) constructs.
• Recommends design or test methods and statistical process
control procedures for achieving required levels of product reliability.
• Complies and analyzes performance reports and process control
statistics; investigates and analyzes relevant variables potentially
affecting product and processes.
• Ensures that corrective measures meet acceptable reliability
standards. Analyzes preliminary plans and develops reliability
engineering programs to achieve company, customer and governmental
agency reliability objectives.
• May develop mathematical models to identify units, batches or processes posing excessive failure risks.
• As necessary, proposes changes in design or formulation to improve system and/or process reliability.
• Utilize standard statistical analysis and problem solving
techniques to determine product acceptance and evaluate process
capabilities.
• Apply sound, systematic problem-solving methodologies in
identifying, prioritizing, communicating, and resolving quality issues.
• Participate in Product Review Boards. Identify non-conformance
trends and develop technical investigation plans. Investigates and
analyze customer/internal complaints.
• Lead and support continuous improvement activities.
• Must comply with requirements of ISO 14001 and BSC
Environmental, Health and Safety standards and follow procedures and
instructions related to these standards.
SUPERVISORY RESPONSIBILITIES:
May Supervise or coach technicians or other engineering support
employees. Trains and/or provides work direction to technicians and
engineers and may train manufacturing personnel when required as part
of a validation.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an
individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge,
skill, and/or ability required. Reasonable accommodations may be made
to enable individuals with disabilities to perform the essential
functions.
MINIMUM REQUIREMENTS: To be considered for this position you must have
the following qualifications: EDUCATION, EXPERIENCE, and/or SKILLS
•Position requires a minimum of a BS / BA from a four-year college or university.
•One or two years experience in a quality or related field.
•Understanding and demonstrated experience in Process Validation (IQ, OQ, PQ)
•Demonstrated interpersonal skills with ability to work within a team environment.
•Strong written/verbal communication skills.
PREFERRED:
•Six Sigma problem solving methodologies
•Understanding of the following Quality Tools and Methodologies: SPC, DOE, GR&R, FMEA, & CAPA
Please mention Number Crunchers' Web Center when you apply. Thanks for your support!
Engineer II, Quality , Boston Scientific, Miami, FL
Requisition ID 26218
Full/Part Time
Location Miami, FL
Job Description
PRIMARY PURPOSE:
To plan and direct activities concerned with development, application
and maintenance of quality standards for manufacturing processes,
materials and products.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES include the following. Other
duties may be assigned. Able to perform the following duties with
moderate supervisory support:
1. Assure compliance with US Regulations and International Countries Specific Regulatory Requirements.
2. Assure compliance with BSC Corporate and Miami Site Policies and Procedures.
3. Comply with International Standards such as: ISO 13485.
4. Drive/participate in MRB’s, CAPA’s and RIN’s
investigation processes. Responsible for Root Cause determination,
driving closure, and determining appropriate action based on analysis
of trend data.
5. Drive corrective actions in response to negative trends in yields,
trended codes and field complaints. Review complaints investigations.
6. Inspection Method determination including: Sampling Plans,
Acceptance criteria, equipment selection, and Test Method Validation
7. Component Quality including Incoming Inspection, Criticality
assessment, Sample Size Selection, Inspection Method determination and
Validation, Inspection Equipment Selection, qualification, and
validation
8. Participates in Deviation Impact Analysis – i.e. –
Calibration deviations, Preventive Maintenance, Issue containment,
CAPA, Environmental Monitoring, etc.
9. Gage R&R Studies
10. First Article Inspection requirements determination –
completion of First Article Requirements Form (FARF), review and
resolution of discrepancies from FARF results.
11. Establishing Statistical Process Control in production
12. Support Process/Product Validations through Sample Size
determination, Normality Testing and Data Analysis. Ensure appropriate
sustainable justification of deviations from protocols and
justification for and Out of Specification (OOS) conditions. Review raw
data for integrity. Develop closing reports.
13. Support of Lean and VIP activities.
14. Assure appropriate justification of Change Requests and inclusion
of appropriate data to ensure compliance. Ensure adequacy of completion
and support for the Initial Regulatory Assessment and Change request
Assessment form.
15. Develop and upgrade department procedures.
16. Participates in department process improvements including: new
technology, procedural changes to improve processes or equipment
parameters, modify optimize SFP.
17. Proactively participates in departments assessments and provide alternatives methods of improvements.
18. Participates in special projects as needed.
19. Participates in supplier evaluation and investigation program related to manufacturing components.
20. Supervise and train quality technicians if required.
21. Prepare presentations related to department quality events.
Internal/External nonconforming products communication. Present in the
applicable forum.
22. Ensure cGMP’s are followed in area(s) of responsibility.
23. New Process Development Quality Engineers - all of the above plus:
24. Compile technical file data to support release of new products where appropriate.
25. Support process development teams in completion of risk management activities.
26. Partner with divisional quality engineers to insure design control
compliance throughout new product development design cycle and product
launch.
27. Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
QUALIFICATION
To perform this job successfully, an individual must be able to perform
each essential duty satisfactorily. The requirements listed below are
representative of the knowledge, skills, and or ability required.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE:
Bachelor’s degree in Mechanical, Industrial or Manufacturing
Engineering and a minimum of 2 - 5 years experience in the quality or
medical device field; or equivalent combination of education and/or
experience is required. ASQ Certified (CQE) recommended. Background in
manufacturing engineering and/or process engineering preferred.
Knowledgeable in advanced statistics, process control, design of
experiments, etc. Ability to develop and write protocols, validation
reports, engineering reports, etc. Experience in developing test
procedures, test equipment, etc. Experience in medical or regulated
industry preferred.
LANGUAGE SKILLS (ENGLISH):
Ability to read, analyze and interpret general business periodicals,
professional journals, and technical procedures. Ability to write
technical reports, business correspondence and procedure manuals.
Ability to effectively present information and respond to questions
from groups of managers, clients, customers and the general public.
MATHEMATICAL SKILLS:
Ability to work with mathematical concepts such as probability and
statistical inferences and fundamentals of plane and solid geometry.
Ability to apply concepts such as fractions, percentages, ratios and
proportions to practical situations. Ability to perform calculations:
to size equipment/machinery, to determine project cost/savings, and to
determine root cause failures.
REASONING ABILITY:
Ability to solve practical problems and deal with a variety of concrete
variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written,
oral, diagram or schedule form. Able to make daily decisions based on
experience, knowledge and analytical/logical thinking. Decision making
at this level is extremely important.
Must be able to make decisions impacting product quality, corrective
actions, etc. Root cause analysis of problems encountered during the
development of a product or in production are required.
OTHER SKILLS AND ABILITIES:
Must be computer literate. Proficient use in current versions of MS
Excel, MS Project, MS Word, and Statistical Analysis software (i.e.:
Mini-tab, Stat-Graphics) preferred.
PHYSICAL DEMANDS: The physical demands described here are
representative of those that must be met by and employee to
successfully perform the essential functions of this job. Reasonable
accommodations may be made to enable individuals with disabilities to
perform the essential functions.
While performing the duties of this job, the employee is frequently
required to sit, and talk or hear. The employee is occasionally
required to stand; walk; use hands to finger, handle, or feel objects;
and reach with hands and arms. The employee must regularly lift and /or
move up to 10 pounds.
WORK ENVIRONMENT: The work environment characteristics described here
are representative of those an employee encounters while performing the
essential functions of this job. Reasonable accommodations may be made
to enable individuals with disabilities to perform the essential
functions.
The noise level in the work environment is usually moderate within an
office environment with some exposure in a manufacturing
environment.
Please mention Number Crunchers' Web Center when you apply. Thanks for your support!
Biostatistics Manager , Boston Scientific, Miami, FL
Requisition ID 26200
Full/Part Time
Location: Marlborough, MA
Job Description
Delivering on the promise of medical innovation begins at Boston Scientific!
By delivering innovative products that help clinicians improve the
lives of patients every single day, Boston Scientific makes a profound
impact on the quality of medical care around the world. As we continue
to transform the field of medical technology, we seek dedicated
individuals who possess the integrity and creative spirit needed to
thrive in an innovative company. Join a global organization that is
fueled by the diversity and talent of its entire workforce.
General Summary:
Manages staff consisting of 3-4 Biostatisticians/Programmers. Takes an
active role in defining the strategy for clinical trials including
recommendation of appropriate research design, definition of patient
population, measurement of outcome variables, and hypothesis
development, specifically, in Drug Eluting Stent Post-Approval studies.
Duties and Responsibilities:
*Authors and provides input on relevant sections of clinical research
protocols including endpoint specification, study logistics, sample
size determination/justification, randomization plans, statistical
analysis plans, interim analysis, and stopping rules.
*Defines programming requirements of trial and ensures timely
completion. Authors or manages the development of Statistical Analysis
plans (SAPs) for assigned projects. Works with Reimbursement and
Outcomes Planning group as required.
*Interfaces with outside biostatisticians when external expertise is
required. Manages CRO biostatistics activities, as appropriate.
*Will be accountable for multiple concurrent clinical studies.
*Will train and mentor biostatistics staff on processes.
*Participates in and assists with the development and approval of
global biostatistics strategies in collaboration with Clinical Sciences
management.
*Manages statistical analysis release and review meetings for clinical
projects; reviews and participates in finalizing and obtaining approval
of final manuscript or final reports for projects.
*Participates in the dissemination of clinical information to the
biostatistics team members and extended core team members, as
appropriate.
*Provides biostatistical support in working with the Food and Drug
Administration (FDA), including 510(k) and Pre-Market Approval (PMA)
submissions, responses to FDA questions, and preparation for FDA
advisory panel.
*Assists in developing and maintaining biostatistics infrastructure
such as the drafting and/or reviewing of SOPs, Guidelines, and Work
Instructions.
Minimum Education & Experience:
*Master’s level degree or equivalent in biostatistics, statistics, or public health; PhD degree preferred.
*At least 5 years experience in biostatistics and medical device or
pharmaceutical clinical trials, with at least 1 year managing staff and
projects, working with clinical professionals within a team, and
working in a cross-functional product development setting.
*Demonstrated computer expertise in SAS programming and word processing; experience using SQL and EDC highly desirable.
*Experience with database systems, in writing scientific protocols, analysis plans and clinical study reports.
Working Conditions:
General office environment, approximately 10-15% travel to clinical or statistical meetings and other BSC facilities.
Boston Scientific (NYSE: BSX) is a worldwide developer, manufacturer
and marketer of medical devices with approximately 25,000 employees and
revenue of $8.3 billion in 2007. For more than 25 years, Boston
Scientific has helped physicians and other medical professionals
improve their patients’ quality of life by providing alternatives
to surgery.
The Marlborough location is conveniently located right off of routes
495 and 85 in a beautiful setting and newly renovated facility.
Please mention Number Crunchers' Web Center when you apply. Thanks for your support!
Engineer, Sr R&D, Boston Scientific,St. Paul, MI
Title Engineer, Sr R&D
Requisition ID 35850
Division Cardiac Rhythm Management
Functional Area Manufacturing Operations
Yrs of Experience 5 - 10
Position Located in St. Paul, Minnesota
The Opportunity #35850 Sr Engineer, R&D (Mechanical)
Job Description
Position Profile:
Responsible for designing, defining and implementing system
requirements for complex customer systems and/or preparing studies and
analyzing existing systems.
Designs, defines, implements system requirements, system
specifications, input/output processes and working parameters by using
current systems engineering methods and technologies.
Documents system requirements by writing documents, reports, memos,
change requests. Methods used are determined by approved procedures and
standards.
Tracks system engineering effort by creating and maintaining records in the approved tracking management tool.
Solves system problems by analyzing the situation and recommending corrective or alternative actions.
Analyzes, coordinates system partitioning (i.e. hardware/software
partitioning) and total system integration by using systems engineering
practices.
Conducts special studies on subjects such as improving systems
engineering practices, improving system quality, subsystem
partitioning, etc. by researching and analyzing options for
implementation.
Continuously improves process and work methodologies by interfacing
with peers/cross-functional groups and analyzing activities to improve
workflow and work processes.
Directs support personnel and project activities.
Mentors engineers in software engineering activities/methodologies and domain knowledge.
Position Qualifications Bachelor's degree plus 6+ years of related work
experience with a strong understanding of specified functional area, or
an equivalent combination of education and work experience. Advanced
degree preferred.
Additional Information Additional requirements and responsibilities
unique to this position:Responsible for the development and
qualification of all components and suppliers required for device
production. This responsibility includes working with manufacturing and
design to insure component specification are clear and complete,
vendor/ component capability is good and long-term quality is within
specification and control. Excellent project management skills are a
must. Ability to influence is vital. Deep analytical and core
engineering capabilitiesGood understanding of statistical methods and
six sigma methodology Previous experience in designing assemblies or
componentsPrevious experience in manufacturing / operation with process
engineering expertisePreferred Qualifications: BSME with 4-6 years
experienceAdvanced degrees preferred but not required Molded Silicone /
Thermoplastics experience preferred
Please mention Number Crunchers' Web Center when you apply. Thanks for your support!
Custom Search
NC
Web Center ("The
Number Crunchers' Web Center") is the fastest growing information
portal of data mining, statistics, operations
research, industrial engineering, business
analytics, and applied math.
NC Web Center is a subsidiary of Vista Products, LLC.
