Overview
Quality Engineer Jobs in Wilmington, MA at Mastech Digital
Title: Quality Engineer
Company: Mastech Digital
Location: Wilmington, MA
Maintaining applicable quality system, environmental, and FDA requirements/certifications.
Facilitate operator owned quality program.
Supporting the MRB and RMA processes.
Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
Prepare FMEA’s, controls plans, quality plans, PPAP.
Coordinate process validations and reduce dependence on inspection.
Generating applicable quality metric reports; cost of quality, management by facts.
Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
Special projects as assigned by quality management.
Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations.
Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements.
Standard problem solving techniques.
Applies statistical and Six Sigma concepts and techniques.
Works with Internal and External Customers.
Participates in audits and inspections.
Writing and maintaining quality related work instructions and procedures.
KNOWLEDGE and SKILLS:
Manufacturing operations – forging and/or machining.
Measuring devices, Quality Systems.
Regulations – FDA, GMP and ISO.
Blueprint reading; GD&T, Metrology.
Problem solving and 8D.
Math skills (algebra, trigonometry) skills.
Microsoft office (Word, Excel, Outlook, PowerPoint).
Minitab.
EDUCATION and EXPERIENCE:
Bachelor’s Degree in Engineering or related field.
OR without a degree, a minimum of 6 years’ experience within the Medical Device Industry, and Certification (ASQ CQE or CMQ/OE).
2 years’ experience in quality within medical device manufacturing industry preferred.
ISO 13485, FDA 820 and customer interaction experience preferred
