Quality Engineer – Medical Device Combination Products / ALP Mfg

SMC Ltd.•Somerset, WI

3d•Onsite

About The Position

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.

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.

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.