Trelleborg Medial Solutions is seeking a Quality Engineer to join their team. The Quality Engineer is responsible for proactively identifying, investigating and resolving potential and existing nonconformances. A strong technical background is required. Experience in a regulated industry (medical device, pharmaceutical, automotive/transportation, etc.) is beneficial. This is a highly customer interfacing role. Advanced verbal and written communication skills are required for navigating potentially sensitive situations in a customer-focused organization.
As a valued team member with Trelleborg, you will enjoy:
- Competitive compensation:
- Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!
- Greater opportunity for impact: You will impact the production of life-saving devices.
- Growth and advancement: Join a global company that loves to promote from within and allows for advancement.
- Bonus
Education and Experience
Required:
- Bachelor Degree in Engineering or other Technical discipline
Desired:
- Lean/Six Sigma certification (Green Belt or higher)
- ASQ Certified Quality Engineer, Reliability Engineer, or Lead Auditor
- Professional training based on ISO 13485, ISO 9001, ISO 14971 and ISO 16949
- Professional training in defect prevention and detection
Job Responsibilities:
The position includes responsibility for leading and supporting Quality Systems and disciplines, including:
- Control of nonconforming material
- CAPA
- Complaint Handling/Customer Feedback
- Equipment Control/Metrology/Calibration
- APQP and Validation
- Document Control
- Supplier Quality
- Internal & External Audits
- Continuous Improvement
Competencies
Statistical tools and techniques (Minitab, SPC, normality, capability, probability, DOE, etc.) Continuous Improvement tools and techniques (Kaizen, 5s, etc.)Root Cause analysis (Ishikawa, FMEA, Is/Is-Not Analysis, 5Why, etc.) Process validation (IQ/OQ/PQ, PPAP, APQP) Test method validation (GR&R, ATMV, etc.) Geometric Dimensioning & Tolerancing VMM/CMM programming Experience with injection molding and/or medical assembly