We are seeking a highly skilled Quality Engineer with experience in Medical Device, Combination Products or Assembly-Label-Pack (ALP) manufacturing. In this role, you will ensure the highest level of product quality, regulatory compliance, and operational excellence across the manufacturing lifecycle. You will be a key contributor to sustaining engineering, continuous improvement, risk management, and quality systems execution.
This Quality Engineering role is responsible for the following:
- 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.
Qualifications Required
- 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.
What SMC has to offer?
- 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
