Senior Medical Device QA Engineer | CAPA & Validation Expert

Stark Pharma; Minneapolis (MN); On-site; USD 90,000 - 120,000; Part time

Job summary

Stark Pharma is seeking a Quality Assurance Engineer for a medical device environment in the Northwest Minneapolis Metro Area. The role focuses on quality systems, CAPA, DHF activities, audits, and product lifecycle support.

Ideal candidates hold a Bachelor's in Engineering or Life Sciences with 5+ years in medical device quality or design assurance and strong knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14971.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 5+ years of medical device quality or design assurance experience.
• Strong knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14971.
• Experience with CAPA, NCs, DHF, audits, and validation activities.
• Familiarity with PLM systems such as Windchill, Agile, or Propel.

Responsibilities

• Manage CAPAs, nonconformances, root cause investigations, and change controls
• Support IQ/OQ/PQ validation activities and review quality documentation
• Maintain DHF documentation and support product lifecycle activities
• Review batch records, work orders, and manufacturing documentation for GMP compliance
• Support incoming inspection, supplier quality, and audit readiness
• Analyze quality metrics and drive continuous improvement initiatives
• Support customer complaint investigations and PLM system updates

Skills

Quality systems

CAPA management

Root cause analysis

Documentation review

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

Windchill

Agile PLM

Propel

Job description

Stark Pharma is seeking a Quality Assurance Engineer for a medical device environment in the Northwest Minneapolis Metro Area. The role focuses on quality systems, CAPA, DHF activities, audits, and product lifecycle support.

Ideal candidates hold a Bachelor's in Engineering or Life Sciences with 5+ years in medical device quality or design assurance and strong knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14971.