Direct Hire Role

Salary range $97.000 to $123,000 ~ DOQ

Performance Bonus

Hybrid Role

Location: Minneapolis, MN

Quality Systems Manager Ideal Candidate Profile

Our client is currently seeking an energetic, responsive and well-organized full time Quality Systems Manager. This position will be responsible for developing, implementing, and maintaining the quality management system. Additionally, the Quality Systems Manager will manage Document Control and CAPA facilitators.

Quality Systems Manager Job Summary

• Take the lead in second and third-party audits, including audit preparation, execution, reporting and follow-up activities.
• Manage the internal audit program from the selection and training of the internal audit group through the implementation of effective corrective actions.
• Responsible for maintaining and improving a quality system which meets the requirements ISO 13485, and FDA QSR.
• Manage CAPA facilitators in customer complaints, and internal CAPA process using failure analysis, development of corrective and preventative actions and trend analysis.
• Perform process and product audits to identify gaps and deficiencies and implement process improvement initiatives utilizing lean techniques.
• Provide leadership in company regulatory matters and support customers regarding their regulatory needs.
• Develop and maintain a Global Quality System model that scales with organizational growth.
• Identify, develop, and maintain relevant QMS training programs to promote quality awareness and ensure compliance to company policies and procedures.
• Partner with quality and operations to implement quality system improvements.
• Implement, maintain, and provide issue resolution regarding the Global Quality System software (ZenQMS).
• Assist in preparation of management review data and presentation.
• Lead, coach, and mentor the QMS team.
  
  

Quality Systems ManagerSkills And Experience

• Bachelor’s degree or 6 years of equivalent work experience.
• 5 years of experience managing quality management systems.
• Experience with ISO 13485:2016 and FDA.
• Lead Auditor Certification.
• Ability to consistently achieve short and long-term business results.
• Ability to prioritize work and manage multiple tasks when needed.
• Ability to follow through on commitments and hold team members accountable.
• Consistently produces work that meets the customer’s requirements.
• Project management skills.
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
• Clear and effective verbal and written communication skills.
• High attention to detail and great organizational skills.
• Ability to work in a fast-paced team environment.
  
  

Desirable Criteria & Qualifications

• Quality systems experience in a manufacturing setting.
• Continuing education; including participation in local chapters, associations, and/organizations.