Quality Manager

Job Title:

Quality Manager Job Description Join our dynamic team as a Quality Manager and lead our Operations Quality Engineers in maintaining and enhancing quality standards and best practices within the organization. Your expertise will be pivotal in managing quality systems, conducting audits, and implementing continuous improvements in a medical device environment. Responsibilities Manage, mentor, and coach Operations Quality Engineers on quality standards and best practices. Provide job direction, training, and conduct performance reviews. Oversee the NCMR system, including tracking and trending NCMRs to identify CAPAs. Communicate nonconformance issues across all levels of the organization. Lead CAPA investigations and implement corrective actions to ensure thoroughness and effectiveness. Manage manufacturing quality problems through systematic root cause analysis and cross-functional collaboration. Create Master Validation Plans for processes transferring to manufacturing. Support process validation activities, including protocol development and execution oversight. Identify supplier issues and drive improvements to reduce incoming non-conformances. Manage supplier quality relationships and facilitate corrective action implementation. Conduct supplier and process audits to ensure compliance with quality standards. Implement Statistical Process Controls (SPC) on production lines to monitor process capabilities. Develop and implement error-proofing mechanisms (poka-yokes) to prevent defects. Support risk management activities in accordance with ISO standards. Maintain and oversee content of the Device Master Record (DMR) for accuracy and compliance. Audit Design History File (DHF) for completeness and accuracy. Support internal and external audits, including client audits conducted on the Operations level. Essential Skills Extensive expertise in manufacturing operations and quality systems in a medical device environment. Deep understanding of ISO and FDA QSR requirements, including design controls and process validation. ISO Lead Auditor certification and experience conducting supplier and process audits. Proficiency in eQMS systems, preferably GAS. Experience with error proofing techniques (poka-yokes) in manufacturing environments. Strong Root Cause Analysis (RCA) capabilities. Proficiency with MS Office applications and business software. Ability to accurately prioritize and execute tasks with minimal direction. Ability to interpret and understand drawing specifications and inspection procedures. Familiarity with inspection devices such as pin gauges, micrometers, and calipers. Broad knowledge of statistics and statistical process control. Additional Skills & Qualifications Bachelor's Degree in engineering or a related STEM field preferred. Equivalent work experience or MBA may substitute. Minimum of 8+ years experience in Quality Engineering Operations in a medical device manufacturing environment. Minimum of 3+ years leading a team of engineers and/or technicians. Experience in process design development and product development team environments. Experience in a manufacturing team environment, catheter assembly preferred. Work Environment We foster a vibrant and engaging work culture where employees and clients alike enjoy a collaborative atmosphere. Our facility features a gym, golf simulator, two lunch rooms, and hosts fun activities like Bacon Fridays. With an exceptional retention rate, our team offers stability and experience, ensuring consistent project success. Job Type & Location This is a Permanent position based out of Minneapolis, MN. Pay and Benefits The pay range for this position is $120000.00 - $140000.00/yr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Minneapolis,MN.

Application Deadline This position is anticipated to close on Mar 6, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.