Quality Engineer – ISO 13485, Continuous Improvement & Audits

Konik; Saint Paul (MN); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan with company match

Gym membership reimbursement

Job summary

Konik is seeking a Quality Engineer in Minneapolis to support products through their lifecycle, lead customer-facing quality initiatives, and improve manufacturing processes using data-driven problem-solving and Lean Six Sigma.

This role partners across Manufacturing, Engineering, Processing, and Supply Chain in an ISO 13485-regulated environment, balancing validation, compliance, audits, CAPAs, and continuous improvement.

Qualifications

• Bachelor's degree in Engineering or equivalent.
• At least four years of quality experience in a regulated manufacturing environment (ISO 13485, FDA QSR, cGMP, cGDP).
• Experience executing IQ, OQ, and PQ validations; supporting audits and quality discussions; managing change and documentation.
• Strong root cause analysis, CAPA, NCR, nonconforming material, GD&T, and cosmetic specifications.
• Ability to manage multiple projects with cross-functional teams; ERP experience preferred (Epicor).

Responsibilities

• Support development and sustaining quality activities for assigned programs, including validation and qualification.
• Lead IQ, OQ, PQ validations; develop related reports and documentation.
• Serve as primary quality contact for customers; address quality concerns and CAPA/SCAR/RA actions.
• Lead customer audits and support ISO 13485 and regulatory audits as assigned.
• Own NCR and MRB processes from investigation to closure using 8D, DMAIC, and A3.

Skills

Root cause analysis

Cross-functional teamwork

Data-driven problem solving

Quality management

Education

Bachelor's degree in Engineering

Tools

Epicor ERP

Job description

Konik is seeking a Quality Engineer in Minneapolis to support products through their lifecycle, lead customer-facing quality initiatives, and improve manufacturing processes using data-driven problem-solving and Lean Six Sigma.

This role partners across Manufacturing, Engineering, Processing, and Supply Chain in an ISO 13485-regulated environment, balancing validation, compliance, audits, CAPAs, and continuous improvement.