Quality Engineer

About the Role

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.

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.

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.

Pay

$100,000 – $120,000

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