Sr Quality Engineer(Sudbury MA)

```This role will be supporting sustaining manufacturing activities for existing medical device

products, supplier management activities, customer satisfaction and design/process

improvement for existing medical devices. In addition, will be a key team member on design

transfer activities for new products. Lastly, this role will be critical for maintaining the risk

management files across all the product lines.

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:

 Supports regulatory and agency inspections, audits, investigations, and inquiries

regarding the control and assessment of product design and manufacturing quality.

 Key opinion leader for the oversight over manufacturing of assigned products,

assuring compliance with DMR and quality system requirements and assuring

complete and correct Device History Records are maintained.

 Lead product and process improvement initiatives.

 Leads and maintains the development, completion, and maintenance of risk

analyses.

 Supports the generation and completion of protocols and reports for product,

process, and test method validations.

 Support the development implementation, and maintenance of defect categories.

 Collaborates with Manufacturing Engineers to review processes for new and existing

products and supports the coordinate of process validations and capability studies.

 Lead the development of various inspection techniques and procedures to ensure

product integrity to design specifications.

 Lead the disposition of non-conforming materials meet all necessary regulatory

requirements, support the investigation process and assure adequacy of corrective

actions to prevent re-occurrence.

 Conducts complaint investigations and remediation recommendations as needed.

 Lead CAPA activities, including analysis of data and trends in complaints, supplier

quality, nonconforming material, training effectiveness, and root causes analysis.

 Conduct Supplier Audits and investigations as needed.

 Provide leadership and oversight for Supplier Qualifications process.

 Leads the product transfers process and the construction of any Device History Files.

EXPERIENCE/SKILL REQUIREMENTS:

 Experience with Microsoft programs and statistical programs (i.e. Minitab)

 Proficiency in statistical tools (i.e. Gage R&R, Capability Analysis, Anova, etc.)

 Proficiency in the use of root cause analysis tools (i.e. FMEA, Fishbone Diagram, 5

Why, 8D, etc.)

 Experience with intravascular catheters and/or electro-mechanical hardware a plus.

 Medical device software experience a plus.

 Experience with sterile product preferred.

 Solid Understand of medical device ISO 13485, FDA 21 CFR 820

 Familiar with MDR (EC) 2017/745/MDD, ISO 14971

 Ability to read and interpret drawings

 Experience and demonstrated proficiency in Process Validation (IQ, OQ, PQ, TMV)

 Proficiency in the usage of Six Sigma Methodologies and Lean concepts

 Knowledge and experience in Risk Management (ISO 14975)

 Detail oriented with strong organization skills

 Ability to work cross functionally and as part of a project team

 Self-Motivated and strong ability to adapt to change

 Experience with conflict management

EDUCATIONAL REQUIREMENTS:

 Bachelor + minimum of 4 years of relevant experience

 Six Sigma Green Belt

 Internal Auditor Certified

 Certified Quality Engineer preferred

Job Type: Full-time

Pay: $90,000.00 - $108,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off

Experience level:

• 3 years
• 4 years
• 5 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Application Question(s):

• Are you ok commuting to Bedford MA at times?(20%)

Education:

• Bachelor's (Preferred)

Experience:

• Continuous Improvement: 1 year (Preferred)
• Quality Engineer: 3 years (Preferred)
• Medical Device: 2 years (Preferred)
• Quality Operations: 2 years (Preferred)
• Risk Management: 1 year (Preferred)

Ability to Commute:

• Sudbury, MA 01776 (Required)

Ability to Relocate:

• Sudbury, MA 01776: Relocate before starting work (Required)

Work Location: In person