Quality Engineer

Quality EngineerThe Quality Engineer develops and improves manufacturing processes and products, validates new equipment and technologies, supports production with continuous improvement on the shop floor, and manages customer complaints along with NCR and CAPA activities. This role leads change requests with customers, ensures compliance with ISO, FDA, and other applicable standards, and collaborates closely with QA Technicians and Quality Inspectors to maintain and enhance overall product quality.ResponsibilitiesDevelop new manufacturing processes and products and revise existing ones to improve quality, efficiency, and reliability.Create and update project-specific quality plans that fully meet customer requirements and internal standards.Work as an integral member of cross-functional teams to support product and process development activities.Develop robust measurement methods to verify that products meet defined quality standards and specifications.Troubleshoot measurement methods and equipment to ensure accuracy, repeatability, and reliability of inspection results.Lead validation activities for new products and technologies, including IQ, OQ, and PQ phases.Serve as the QA lead for equipment validation to ensure new equipment meets regulatory and internal quality requirements.Collaborate with customers and suppliers to define and refine new product processes and quality expectations.Lead the management of customer complaints and supplier SCARs, ensuring timely investigation and resolution.Compile and analyze statistical data to evaluate process capabilities and identify improvement opportunities.Conduct PFMEA, GR&R, and SPC studies to assess and control process risks and variation.Create and maintain quality system documentation, including quality plans, inspection plans, control plans, and work instructions.Manage NCRs, CAPAs, and customer complaints from creation through root cause analysis, corrective action, verification, and closure.Apply structured problem-solving tools and work within cross-functional teams to resolve quality issues effectively.Lead production changes while ensuring compliance with customer agreements, ISO standards, and internal requirements.Prepare, submit, and track change requests (SCR) with customers, ensuring clear communication and approval.Support production in achieving APU objectives by providing quality engineering expertise and guidance.Generate and report quality KPIs for PSM2 and other performance tracking needs.Perform internal and external audits to verify compliance with quality system requirements and drive improvements.Provide backup support for other Quality Engineers on customer or internal tasks as needed.Identify, lead, and support continuous improvement initiatives across processes and products.Participate in LEAN and LEAP workshops to drive waste reduction, process optimization, and cost savings.Contribute to risk management activities and ensure that nonconforming material is appropriately controlled and dispositioned.Essential SkillsBachelor's degree in Manufacturing Engineering or a related technical field.Minimum two years of relevant quality engineering experience.Strong blueprint reading skills with a solid understanding of GD&T.Hands-on experience developing manufacturing quality plans for production environments.Demonstrated experience conducting process capability studies, GR&R, PFMEA, and SPC.Proven experience working with NCR and CAPA processes from initiation through closure.Experience working in an ISO-regulated environment, preferably within a medical or similar regulated industry.Proficiency with quality management systems and quality management principles.Working knowledge of corrective action planning and root cause analysis methods.Proficient PC skills in a Windows environment, including common office and data analysis tools.Effective written and verbal communication skills for interaction with cross-functional teams, customers, and suppliers.Strong interpersonal and teamwork skills with the ability to collaborate across departments.Experience with validation activities, including equipment and process validation.Understanding of quality control, quality assurance, and quality management practices in a manufacturing setting.Additional Skills & QualificationsExperience in a precision machine shop environment, preferably in medical device or similar high-precision manufacturing.Experience with PPAP and other advanced product quality planning tools.Experience in supplier quality management and SCAR handling.Familiarity with nonconforming material control and documentation requirements.Experience optimizing manufacturing processes to achieve ongoing cost reductions and efficiency gains.LEAN and/or Six Sigma training with demonstrated application of continuous improvement tools.Demonstrated use of structured problem-solving methodologies such as 8D.Experience performing internal and supplier audits to ISO and related standards.Exposure to risk management practices within a regulated manufacturing environment.Experience working within an ERP system to support quality and production activities.Knowledge of medical device quality expectations and FDA-related quality practices is a plus.Ability to thrive in a growing organization that is investing in new capabilities and technologies.Job Type & LocationThis is a Permanent position based out of Big Lake, MN.Pay and BenefitsThe pay range for this position is $80000.00 - $120000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Health & Insurance Benefits: - Medical plans = company contributes a generous portion of the premium cost. - Dental plan = employer?supported. - Voluntary vision plan = low?cost, employee?elected. - Basic Life Insurance = 100% employer?paid. - Accidental Death & Dismemberment (AD&D) = 100% employer?paid. - Short?term disability = 100% employer?paid. - Long?term disability = 100% employer?paid. - Employee Assistance Program (EAP) = 100% employer?paid. Retirement & Savings: - Retirement contributions (details referenced in the summary, plan documents hold the specifics). Spending Accounts: - Flexible Spending Accounts (FSA) - Dependent Care FSAWorkplace TypeThis is a fully onsite position in Big Lake, MN.Application DeadlineThis position is anticipated to close on Aug 31, 2026.