Senior Quality Supervisor (Coon Rapids)

Hours: Monday - Friday (8 hour days) Position Summary: The Senior Quality Supervisor is responsible for leading the quality technician and programming teams to ensure compliance with ISO 13485, FDA regulations, and customer requirements. This role drives continuous improvement, oversees quality system activities, and acts as a key liaison between production, customers, and the Director of Quality. The Senior Quality Supervisor ensures effective execution of validations, CAPAs, complaints, and change controls while fostering a culture of accountability and excellence. Key Responsibilities: This position is primary responsible to: • Supervise and mentor QA Technicians and Quality Programmers to ensure alignment with quality objectives and professional development. • Provide mentorship and guidance to the QA Supervisor. • Allocate resources and prioritize tasks to meet quality and production goals, ensuring timely execution of validations, investigations, and documentation. • Act as the primary quality contact for escalated customer complaints, SCARs, and change requests, leading structured problem-solving efforts (e.g., 8D). • Collaborate with cross-functional teams (Engineering, Production, Supply Chain) to resolve quality issues and implement improvements. • Ensure compliance with ISO 13485, FDA, and customer-specific requirements across all quality activities. • Oversee creation and maintenance of quality documentation including inspection plans, work instructions, and validation protocols. • Lead internal and external audits, ensuring timely closure of findings and robust corrective actions. This positions' secondary responsibilities are: • Monitor and report on quality KPIs, including NCRs, CAPAs, validation status, and audit results. • Drive continuous improvement initiatives using LEAN and Six Sigma principles. • Support deployment and optimization of quality tools and software (e.g., SPC systems, ERP). • Promote a strong HSE culture by modeling safe behaviors and ensuring team adherence to safety protocols. • Participate in risk assessments, incident investigations, and HSE improvement initiatives. • Contribute to employee training and development within the quality team. • Perform other duties as assigned by the Director of Quality. Required Qualifications: • Bachelor's degree in manufacturing engineering or related field (or equivalent experience) • Minimum 5 years of experience in quality roles, with at least 2 years in a leadership or supervisory capacity, including direct oversight of technicians and cross-functional teams. • Blueprint reading is mandatory - GD&T level expected • Demonstrated success in cross-departmental collaboration, especially with Engineering, Production, Supply Chain, and Customer Service teams. • Experience developing manufacturing quality plans. • Experience conducting process capability, GR&R, PFMEA and SPC studies. • Experience working on NCR / CAPA. • Experience working in an ISO 13485 environment • Proficient PC skills in a Windows environment. • Effective written and verbal communication skills. • Strong interpersonal and teamwork skills. • Experience in internal/external and supplier audits. Preferred Qualifications: • Experience in a precision machine shop environment. • Experience optimizing processes to achieve ongoing cost reductions. • LEAN / Six Sigma training and demonstrated application. • Demonstrated use of structured problem-solving methods (i.e. 8D, 5Why's, Fishbone). • Experience using an ERP system. • Experience of managing a staff or cross functional team lead for senior position Physical Demands • Must be able to sit, grasp items and perform keyboarding frequently. • Must be able to reach, stretch and occasionally lift up to 30 lbs. • Must be able to travel occasionally. Sensory Requirements • Normal vision. • Normal hearing. • Ability to communicate verbally. Health, Safety & Environment responsibilities and skills: • Participate in the development and promotion of the HSE culture • Be exemplary in terms of health, safety and the environment, in particular by : o Respecting and ensuring respect for the instructions and rules established in the field of health, safety and the environment (in particular the LISI golden rules) o Immediately correcting, whenever possible, or reporting to his or her superiors and/or the HSE department, any malfunction or risky situation in the fields of health, safety and environmental protection o Implementing preventive actions to reduce the environmental footprint and control health and safety risks • Participate, upon request, in analyses (of risks, incidents) and HSE working groups related to his/her professional scope • Be familiar with the main health and safety risks and the main environmental impacts relating to the scope of his/her work • Be familiar with the site's HSE policy and objectives • To be able to make proposals for improving working conditions and limiting environmental impact Compensation and Benefits Overview Starting Pay Range for this position is $38-$45/Hour Minimum pay rates offered will comply with applicable county or city regulations if they exceed the listed range. Actual pay rates are determined based on various factors, including but not limited to, local labor market conditions, years of relevant experience, education, professional certifications, foreign language proficiency, and other job-specific qualifications. Employees and their families are eligible to participate in a comprehensive benefits package, including company-sponsored medical, dental, vision, flexible spending accounts (FSA), health savings accounts (HSA), voluntary benefits, supplemental life/AD&D insurance, and the company's 401(k) plan. Additional benefits include access to an employee assistance program (EAP) for employees and household members, long-term disability coverage, and short-term disability for full-time employees. Full-time and Part-time employees receive Paid Time Off (PTO) based on years of service, as well as paid holidays, personal holidays and MN Safe and Sick Time.

Created: 2026-03-10