Quality Manager
Our client is a public company that has brought to the market first in class, innovative medical products. With their excellent reputation for recognized quality, they are growing and looking for a leader to manage a broad area of responsibility as a Senior Quality Manager.  This position will lead their quality system, help cross functionally in new product development and launch into manufacturing, training, lean opportunities and initiatives, manufacturing issues and corrective actions as well as FDA and ISO audits.

With a leadership team that has a competitive mind-set in the market and a culture of people who are enthusiastic about the work they do, and the patients’ lives they impact, this is a great opportunity to have an impact within the organization with your leadership, experience and in the products you make.

We are searching for a talented Leader focused on Quality with a strong LEAN background. This person will be responsible for providing leadership, employee development and focus to your team. This position will be involved in all aspects of quality, from maintenance of the documented ISO 13485 quality system and in participating and leading FDA and ISO audits, ensuring product quality meets expectations. Our client is currently implementing a new Quality System software as their new quality system platform. With initial work already completed in the document control and training modules, this position will lead implementation of future modules including CAPA, equipment, non-conforming material, complaints, internal audit, and design control. If you are excited to be part of a winning team, this is a great place to grow your career and a great time to join!

Roles & Responsibilities:

  • Collaborate with the management team to set quality benchmarks.
  • Provide leadership for ISO 13485 Quality System and ensure ongoing successful audits.
  • Document requirements in accordance with industry standards and customer expectations.
  • Identify quality control processes to ensure criteria are met.
  • Manage and mentor the Quality Inspector and Quality Engineer.
  • Monitor tests to check final product adherence to the company standards.
  • Record findings and relay information to the production team.
  • Brainstorm ideas to increase productivity and performance of the production line while maintaining accuracy in quality.
  • Make crucial decisions in favor of cost-efficiency without compromising on quality.
  • Prioritize tasks to keep production running when issues arise.
  • Participate in Industry and FDA audits.
  • Contributing member of the new product design team.

Required Skills & Experience:

  • Experience in an FDA regulated industry.
  • Experience as a manager in a medical device manufacturing environment.
  • Familiar with company and industry quality standards and processes both domestic and foreign including ISO 14971, ISO 13485, EU MDD and EU MDR.
  • LEAN certified
  • Team player and strong leader with excellent management and people skills.
  • Proficient in software systems, and Microsoft Office applications.
  • Knowledge of market trends and conditions.
  • Exceptional analytical and problem-solving abilities.
  • Position is located South West of the Minneapolis, MN area
  • Position reports to Senior Director of Quality & Regulatory

About Versique

Versique is one of the largest recruiting firms in the Midwest and specializes in both consulting and permanent placement. With a valuable blend of functional, industry and recruiting experience, our award-winning team of headhunters has a proven history of delivering exceptional talent acquisition solutions. The Versique brand represents a powerful combination of “versatile” and “unique” as it hints at the concept of “search” in its pronunciation: ver-seek.

Versique is an equal opportunity employer committed to creating a diverse workforce. We consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability, or veteran status, among other factors.


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Quality Manager

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