Quality Engineer

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

Quality Engineer

Minneapolis | Direct Hire | $100,000 - $120,000

Join a growing, highly regulated manufacturer where quality engineering plays a direct role in product performance, customer satisfaction, and operational improvement. This position offers the opportunity to support products throughout their lifecycle, lead customer-facing quality initiatives, and improve manufacturing processes using data-driven problem-solving and Lean Six Sigma methodologies.

The Quality Engineer will serve as a key quality partner across Manufacturing, Engineering, Processing, and Supply Chain. This role is ideal for an experienced quality professional who enjoys balancing validation, compliance, customer support, nonconformance management, and hands-on continuous improvement within an ISO 13485-regulated environment.

Quality Engineer Responsibilities

• Support development and sustaining quality activities for assigned programs, including part validation, qualification, ongoing compliance, and participation in the organization’s Stage-Gate product realization process.
• Execute validation and quality-planning activities, including IQ, OQ, and PQ protocols and reports, Process Flow Diagrams, Process FMEAs, Control Plans, work instructions, and inspection instructions.
• Serve as the primary quality contact for assigned customers, addressing quality concerns, investigations, corrective actions, CAPAs, SCARs, RMAs, and sustaining program requirements.
• Lead customer audits for assigned programs and products, including preparation, participation, documentation, response coordination, and corrective actions. Participate on the internal audit team and support ISO 13485 and applicable regulatory audits as assigned.
• Own NCR and MRB processes, including the investigation, disposition, risk assessment, corrective action, and closure of internally produced nonconforming material. Apply root cause analysis and structured problem-solving methods such as 8D, DMAIC, and A3 to implement effective and sustainable CAPAs.
• Drive continuous improvement by analyzing quality and production data to identify trends and reduce defects, scrap, rework, and customer complaints. Partner with Manufacturing, Engineering, Processing, Production, and Supply Chain to standardize improved processes, update Control Plans and work instructions, ensure shop-floor adherence, and provide guidance on quality issues.
• Coach and train operators, technicians, and supervisors on quality tools, standard work, root cause analysis, and problem-solving methods to strengthen a culture of quality and continuous improvement.

Quality Engineer Qualifications

• Bachelor's degree in Engineering or an equivalent combination of education and relevant work experience.
• At least four years of quality experience within a regulated manufacturing environment, including working knowledge of ISO 13485, applicable FDA quality system requirements, cGMP, and cGDP practices.
• Demonstrated experience executing IQ, OQ, and PQ validations; supporting customer audits and quality discussions; and managing change control, revision control, and regulated documentation.
• Strong experience with root cause analysis, corrective and preventive action, nonconforming material, print reading, GD&T, and cosmetic specifications.
• Ability to manage multiple projects concurrently while collaborating effectively with customers and cross-functional manufacturing teams.
• Experience using Epicor or a similar ERP system is preferred.
• Valid identification and legal authorization to work in the United States are required.

Benefits

• Three weeks' PTO
• Paid sick time
• Medical insurance
• Dental insurance
• Vision insurance
• Short-term and long-term disability coverage
• Group basic life insurance
• Voluntary life insurance
• Hospital, accident, and critical illness coverage
• Pet insurance
• Identity theft and legal services coverage
• 401(k) plan with company match
• Gym membership reimbursement
• Tobacco cessation reimbursement

Konik is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.

Konik has been a leader in the technical staffing industry for more than 50 years, providing the fastest and easiest link between employees and employers. Konik has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception and maintains a strong commitment to customer service.

Compensation

$100,000-$120,000 per year