Lead Quality Engineer - Medical Devices

PROMED MOLDED PRODUCTS INC; Plymouth (MN); On-site; USD 83,000 - 114,000; Full time

Benefits offered by this job

401k with company match

Medical Insurance

Dental Insurance

Vision Insurance

Job summary

Promed Molded Products Inc. in Plymouth, MN, seeks a Quality Engineer lead for new product development and day-to-day manufacturing support to ensure parts meet established standards and customer expectations. The role emphasizes collaboration with Operations and Engineering to sustain production quality.

You will manage CAPA, PFMEA, audits, and process improvements, driving efficiency and quality. A background in medical devices and strong communication are essential.

Qualifications

• Requires an Engineering/Science degree with medical device background.
• Experience in Medical/Cleanroom industry.
• Knowledge of 21 CFR 4, 210, 211 and ISO 13485.
• Proficient in MS Office (Word, Excel, PowerPoint, Outlook) and project management.
• Strong communication and problem-solving abilities.
• Ability to work with minimal supervision and meet deadlines.

Responsibilities

• Adheres to 21 CFR 820, 210, 211 and ISO 13485.
• Develops and revises operating practices and procedures.
• Leads investigation when production issues arise and supports CAPA.
• Creates and reviews PFMEAs for new projects and existing lines.
• Qualifies/validates processes and equipment to meet objectives.
• Supports supplier quality and internal audits.

Skills

Communication

Problem solving

Time management

Cross-functional collaboration

Education

Engineering/Science degree with medical device background

Tools

MS Office

Minitab

CMM

Job description

Promed Molded Products Inc. in Plymouth, MN, seeks a Quality Engineer lead for new product development and day-to-day manufacturing support to ensure parts meet established standards and customer expectations. The role emphasizes collaboration with Operations and Engineering to sustain production quality.

You will manage CAPA, PFMEA, audits, and process improvements, driving efficiency and quality. A background in medical devices and strong communication are essential.