Facility Quality / Regulatory Manager

Fond du Lac

Position Summary

Do you want to work in an easygoing, yet hardworking environment? Do you want to play a pivotal role in a company that manufactures its own FDA Class I and Class II medical devices? Do you have experience planning, directing, and coordinating quality assurance programs? If you answered yes to these questions, then we have the opportunity for you! For more information about our company, see www.grahamfield.com

General Accountabilities in this Role:

  • Ensure compliance to FDA, QSR, cGMP, ISO 13485:2016 / MDSAP.
  • QSIT Subsystems: Management Controls, Design Controls, CAPA, Production and Process Controls, and
  • Process Improvements.
  • Interface with the FDA and Notified Bodies. Serves as the Facility Management Representative.
  • Conduct annual internal audits across the company with other team members.
  • Work cohesively with the operations and engineering teams to bring new products to market.
  • Validate and audit Supplier Quality Systems (Supplier Evaluations).
  • Participate in the investigation of all Potential Safety Concerns. Audit trending data to identify, analyze and implement corrective actions.
  • Oversee the onsite quality team.

Summary Job Requirements:

  • Bachelor’s Degree.
  • Strong statistical analysis and quality engineering principles.
  • Hands on work experience performing similar duties.
  • Equivalent combination of education and experience.
  • Supervisory experience.
  • Sound understanding of Quality System Requirements, ISO 13485:2016 / MDSAP and CE regulations.
  • ISO 13485 and MDSAP Internal Audit Certifications are a plus.
  • Ability to lift and move 25 to 50 pounds.
  • Strong independent work ethic and ability to multitask.
  • Must be able to travel occasionally.

The Rewards:

Comprehensive Benefit Package

  • 401(k) with Company Match
  • Competitive Health, Dental and Vision insurance plans
  • Paid Vacation, Holidays and Personal Days
  • Paid Life Insurance, Employee Assistance Program and Short-Term Disability

To apply for this position please send a cover letter and resume to hr@grahamfield.com

All qualified applicants will receive consideration for employment without regard to race, color, gender identity or expression, age, religion, height, weight, AIDS/HIV status, intellectual disability, mental disability, physical disability, including but not limited to blindness, unless it is shown that such disability prevents performance of the work involved, medical condition, handicap, national origin, ancestry, sexual orientation, marital status, domestic partnership status, parental status, military status, veteran or military discharge status, political beliefs, organizational affiliations, source of income or housing status or any other status protected by applicable law. GF Health Products, Inc. is a drug free workplace.

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