Senior Quality Engineer
Position: Senior Quality Engineer
Location: Devens, MA
Essential Job Duties and Responsibilities:
· Create and maintain pFMEA’s, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols and reports.
· Analyze FAIRs, process and test method validation data before sending to the customer.
· Lead customer complaint and CAPA investigations as required.
· Manage ECOs, deviations, and documentation updates as required.
· Generate and maintain applicable quality system documentation as needed.
· Manages activities for handling healthcare products from receiving to shipping.
· Assessing and ensuring compliance through training, auditing, and corrective and preventive actions.
· Participate in customer audits and provide input to any observations.
· Train personnel as required
· Review and discuss daily rejects and implement action plans
· Make appropriate changes to prevent recurrence of quality related issues.
· Make appropriate changes to fixtures or inspection methods and tools as required.
· Regular attendance and professionalism.
Essential Qualifications:
· Bachelor of Science Degree
· 10+ years of experience as a Quality Engineering in the healthcare industry
· Must have experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation
· Must be able to read and understand 2D detailed part/article drawings
· Must understand the use all quality related inspection equipment
· Must have excellent problem solving and mistake proofing skills
· Must have computer skills and familiarity with Word and Excel programs
· Must have knowledge of SPC
· Effective interpersonal and problem-solving skills
· Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization
· Excellent written, verbal, and presentation skills
Job Type: Full-time
Pay: $100,000.00 - $110,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
People with a criminal record are encouraged to apply
Education:
Bachelor's (Required)
Experience:
medical device / Healthcare: 10 years (Required)
Quality assurance: 10 years (Required)
ISO 13485: 5 years (Required)
21 CFR Part 820: 6 years (Required)
Ability to Relocate:
Devenscrest, MA: Relocate before starting work (Required)
Work Location: On the road