Quality Engineer – Medical Device Combination Products / ALP Mfg

About the role

We are seeking a highly skilled Quality Engineer with experience in Medical Device, Combination Products or Assembly‑Label‑Pack (ALP) manufacturing.

Responsibilities

• Provide Quality Engineering support for combination products, ALP manufacturing lines, and medical device operations.
• Ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and applicable global regulatory requirements.
• Support validation activities including IQ/OQ/PQ, process validation, equipment qualification, and test method validation.
• Participate in or lead risk management activities per ISO 14971, including DFMEA, PFMEA, hazard analyses, and control strategy development.
• Own and maintain Quality System documentation including work instructions, specifications, and control plans.
• Lead or support investigations for nonconformances, deviations, and customer complaints through root cause analysis using tools such as 5 Whys, Fishbone, Fault Tree Analysis, or DOE.
• Develop and implement effective Corrective and Preventive Actions (CAPA); verify and validate effectiveness.
• Monitor manufacturing risks and develop mitigation strategies focused on patient safety and product quality.

Requirements

• 5+ years of experience in medical device combination product quality engineering or ALP manufacturing, assembly operations, or packaging/labeling processes.
• Experience with sterile barrier packaging, labeling control systems, or drug‑device interface considerations.
• Working knowledge of ISO 13485, ISO 14971, FDA QSR, and applicable combination product regulations.

Qualifications

• Master's degree in a relevant field (e.g., Quality Engineering, Biomedical Engineering, etc.) preferred.
• Strong understanding of GMPs, cGMPs, and regulatory requirements.
• Excellent problem-solving and critical thinking skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite and other relevant software.

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
Amazing co-workers
Tuition reimbursement
Employee Assistance Program

Pay

Competitive salary based on experience and qualifications.

Schedule

Full-time position with flexible scheduling options.

Skills

Strong analytical and problem-solving skills.

Benefits

At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions.

Company Information

At SMC Ltd. we are committed to fostering a diverse and inclusive workplace where everyone feels valued and respected. We are proud to be an equal opportunity employer and welcome applications from individuals of all backgrounds.