Operations Quality Manager
Precera Medical, Big Lake, MN, United States
Job Description
Posted Tuesday, April 21, 2026 at 6:00 AM
Position Summary:
The Operations Quality Manager – Big Lake is responsible for the day‑to‑day execution of the Quality function at the Big Lake facility. This role provides strong technical leadership in quality engineering and ensures effective implementation of the Quality Management System, product quality, and manufacturing support.
This role is deeply embedded in operations, driving problem‑solving, process control, and product quality performance.
Key Responsibilities
Site Quality Execution
Lead all Quality activities at the Big Lake site including inspection, quality engineering, and compliance
Ensure execution of manufacturing and product‑specific quality plans (control plans, inspection plans, validation)
Partner closely with production to ensure quality at the source
Technical Quality Engineering Leadership
Drive application of core quality tools:
PFMEA
GR&R
SPC
Root cause analysis (8D, 5 Why)
Provide hands‑on support for process validation, capability improvement, and issue resolution
Lead problem‑solving on nonconformances and customer issues
CAPA & Compliance
Own site‑level CAPA execution and timeliness
Support internal and external audits and ensure closure of findings
Ensure adherence to ISO 13485 and FDA requirements
Material Review & Product Disposition
Lead the Material Review Board (MRB) process
Ensure timely and appropriate disposition of non‑conforming material
Partner with the Director of Quality and Sr. Quality Supervisor to provide leadership to the site Quality team.
Provide coaching and technical development to the team
Support hiring and training as needed
Metrics & Performance
Track and report site‑level quality metrics
Identify trends and drive corrective actions to improve performance
Required Qualifications
Bachelor’s degree in Engineering or related field (or equivalent experience)
8–12 years Quality experience in manufacturing
Strong hands‑on experience with quality engineering tools and methods
Experience in ISO 13485 / FDA‑regulated environment
Demonstrated problem‑solving and technical leadership skills
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
Compensation and Benefits Overview
Starting Pay Range for this position is $120,000-$140,000/Annually.
Minimum pay rates offered will comply with applicable county or city regulations if they exceed the listed range. Actual pay rates are determined based 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.
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Posted Tuesday, April 21, 2026 at 6:00 AM
Position Summary:
The Operations Quality Manager – Big Lake is responsible for the day‑to‑day execution of the Quality function at the Big Lake facility. This role provides strong technical leadership in quality engineering and ensures effective implementation of the Quality Management System, product quality, and manufacturing support.
This role is deeply embedded in operations, driving problem‑solving, process control, and product quality performance.
Key Responsibilities
Site Quality Execution
Lead all Quality activities at the Big Lake site including inspection, quality engineering, and compliance
Ensure execution of manufacturing and product‑specific quality plans (control plans, inspection plans, validation)
Partner closely with production to ensure quality at the source
Technical Quality Engineering Leadership
Drive application of core quality tools:
PFMEA
GR&R
SPC
Root cause analysis (8D, 5 Why)
Provide hands‑on support for process validation, capability improvement, and issue resolution
Lead problem‑solving on nonconformances and customer issues
CAPA & Compliance
Own site‑level CAPA execution and timeliness
Support internal and external audits and ensure closure of findings
Ensure adherence to ISO 13485 and FDA requirements
Material Review & Product Disposition
Lead the Material Review Board (MRB) process
Ensure timely and appropriate disposition of non‑conforming material
Partner with the Director of Quality and Sr. Quality Supervisor to provide leadership to the site Quality team.
Provide coaching and technical development to the team
Support hiring and training as needed
Metrics & Performance
Track and report site‑level quality metrics
Identify trends and drive corrective actions to improve performance
Required Qualifications
Bachelor’s degree in Engineering or related field (or equivalent experience)
8–12 years Quality experience in manufacturing
Strong hands‑on experience with quality engineering tools and methods
Experience in ISO 13485 / FDA‑regulated environment
Demonstrated problem‑solving and technical leadership skills
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
Compensation and Benefits Overview
Starting Pay Range for this position is $120,000-$140,000/Annually.
Minimum pay rates offered will comply with applicable county or city regulations if they exceed the listed range. Actual pay rates are determined based 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.
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