Lead Quality Engineer - Medical Devices

Automatic Data Processing, Inc.; Plymouth (MN); Sur place; USD 83 000 - 114 000; Plein temps

Avantages offerts par ce poste

401k with company match

Profit Sharing Program

Medical Insurance

Health Savings Account

Dental Insurance

Vision Insurance

Life Insurance

Paid Family Medical Leave and Long‑Val

Disability Insurance

Pet Insurance

Résumé du poste

ProMed in Minnesota is seeking a Quality Engineer to lead product-line quality efforts, support new product development, and ensure compliance with medical device regulations. You will drive CAPA, process validation, and changes while partnering with Operations and Engineering.

The role emphasizes strong documentation, data analysis, and cross-functional collaboration to maintain production quality and meet customer expectations.

Qualifications

• Engineering/Science degree with drug/medical device-related background; minimum 3 years’ experience in the field.
• Experience in the Medical/Cleanroom industry.
• Knowledge of medical device regulation (21 CFR 4, 210, 211, 820), QMS ISO 13485, risk management (ISO 14971).
• Intermediate knowledge of Microsoft Office products (Word, Excel, PowerPoint, Outlook, and Project).
• Commitment to continuous improvement; excellent communication and interpersonal skills; strong organizational and time-management abilities.
• Ability to establish priorities and meet deadlines.

Responsabilités

• Adheres to 21CFR 820, 210, 211 and ISO 13485.
• Develops and revises standard operations and practices.
• Leads investigations when production issues arise.
• Manages CAPA and other quality systems activities.
• Supports new product development and process validation.
• Meets attendance expectations and performs other duties as needed.

Formation

Engineering/Science degree

Outils

MS Office Suite

CMM

SPC

Minitab

Description du poste

ProMed in Minnesota is seeking a Quality Engineer to lead product-line quality efforts, support new product development, and ensure compliance with medical device regulations. You will drive CAPA, process validation, and changes while partnering with Operations and Engineering.

The role emphasizes strong documentation, data analysis, and cross-functional collaboration to maintain production quality and meet customer expectations.