Supplier Quality Engineer
SMC LtdHighlight
Summary
About the Role
About You
- Bachelor’s degree in Engineering or a related technical discipline.
- 2–4 years of experience in a Supplier Quality role within the medical device manufacturing industry.
- Strong knowledge of ISO 13485:2016 and 21 CFR Part 820 requirements.
- Hands-on experience with Gage R&R, CpK/PpK studies, and Design of Experiments (DoE).
- Proficiency in validation/qualification activities (IQ, OQ, PQ).
- Solid knowledge of risk management standards (ISO 14971) and application of risk assessment techniques such as FMEA.
- Familiarity with quality processes and tools including CAPA, PPAP, and Root Cause Analysis.
- Experience planning and conducting supplier audits.
- Strong understanding of ISO 13485 quality systems.
- Proficient in Minitab and the Microsoft Office Suite.
- Excellent interpersonal, verbal, and written communication skills.
- Experience with metrology equipment and inspection techniques.
- Proficiency in CMM and MicroVu programming.
- Project Management training or certification (e.g., PMP).
- Six Sigma Green Belt certification or demonstrated application of Lean Six Sigma methodologies.
- Certified Lead Auditor or completion of recognized lead auditor training.
Benefits
- Clean, Climate-Controlled Environment
- Stable schedule
- Paid holiday and PTO
- Health, dental, and vision insurance
- 401(k) retirement savings
- Life and disability insurance
- Promotional opportunities
- Training and career growth programs
- Tuition reimbursement
- Employee Assistance Program
SMC Ltd. offers global solutions, contract manufacturing and molding services for the medical device, diagnostics, and pharmaceutical industries. Services include design, engineering, thermoplastic molding including insert, two-shot and micro, liquid silicone injection molding (LIM) and complete device assembly. Project integration, supply chain management, validation, packaging and labeling, and sterilization responsibility are systematically controlled. Facilities offer ISO 13485, quality systems, white room, class 7 and 8 clean rooms. SMC Group: Oval Medical Technologies, an SMC Ltd. company, is a medical device company developing in revolutionary autoinjector platforms. Oval’s unique approach allows for devices that are smaller, easier and safer to use than any other device currently available. Pharmaceutical partners can utilise Oval’s technology to deliver viscous formulations and sensitive biological drugs that would otherwise not be possible to deliver in current marketed injectable devices. Oval is able to tailor the technology for specific patient populations producing devices that are truly patient centric. www.ovalmedical.com