Quality Engineer – Medical Device Combination Products / ALP Mfg

Smc Ltd.; Town of Somerset (WI); On-site; USD 70,000 - 105,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) retirement

Job summary

SMC Ltd. in Somerset, WI, is seeking a Quality Engineer to ensure regulatory compliance and product quality across medical device and ALP operations.

You will lead risk management, CAPA, and validation activities, and maintain quality system documentation, while collaborating with manufacturing teams.

Qualifications

• 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.

Skills

Quality Engineering

Medical Device

ALP manufacturing

Risk management

CAPA

IQ/OQ/PQ

FDA QSR

ISO 13485

ISO 14971

DFMEA

PFMEA

Tools

5 Whys

Fishbone

Fault Tree Analysis

DOE

Job description

Quality Engineer – Medical Device Combination Products / ALP Mfg

Somerset, WI, US

3 days ago Requisition ID: 3827

About Us:

SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

About the Role

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
• Paid holiday and PTO
• Health, dental, and vision insurance
• 401(k) retirement savings
• Life and disability insurance
• Promotional opportunities
• Training and career growth programs
• Employee Assistance Program

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. Please let us know if you require reasonable accommodations during the interview process.

SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.