Senior Quality Supervisor; Coon Rapids

441 93rd Ave, Coon Rapids, MN 55433, USA

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.

• 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.
• 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.

• 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.

• 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, 5
  
  Why’s, Fishbone).
• Experience using an ERP system.
• Experience of managing a staff or cross functional team lead for senior position.

• 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.

• Normal vision.
• Normal hearing.
• Ability to communicate verbally.

• Participate in the development and promotion of the HSE culture.
• Be exemplary in terms of health, safety and the environment, in particular by:
• 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).
• Immediately correcting, whenever possible, or reporting to his or her superiors and/or the HSE…