Quality Engineer

Konik•Saint Paul, MN

15d•Onsite

About The Position

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.

Requirements

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.
Valid identification and legal authorization to work in the United States are required.

Nice To Haves

Experience using Epicor or a similar ERP system is preferred.

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.