Senior Quality Manager - Elgin- Medical Devices

Michael Page

Job Description

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Summary

Our latest client is a Class I/Ii distributor and manufacturer that has been in business for over 30 years. They have a national presence and pride themselves on high quality affordable products. They seek a Senior Quality Manager to oversee the entire Quality function.

Client Details

Our latest client is a Class I/Ii distributor and manufacturer that has been in business for over 30 years. They have a national presence and pride themselves on high quality affordable products. They seek a Senior Quality Manager to oversee the entire Quality function.

  • Oversee a team of 10, including 1 Quality Manager, 2 Quality Engineers and 7 Inspectors
  • Report to the President
  • Maintain and lead all QMS activity

Description

The Senior Quality Manager will be responsible for the following;

  • Primary responsibility for establishing and maintaining compliance of processes and procedures to the US Quality System Regulations, ISO 13485 and Medical Device Regulation.
  • This role will manage, lead and mentor the Quality team.
  • Develop and coach Quality associates to maximize potential and enhance engagement.
  • Hire, train, and set goals with the team that align with Organizational and Functional objectives.
  • Be an active participant on cross-functional teams, representing the Quality function.
  • Drive an effective Management Review process to ensure the suitability and effectiveness of QMS
  • Manage the implementation, maintenance and governance of Quality Management System to ensure compliance with applicable regulations
  • Maintain compliance audit program.
  • Manage compliance training program including role-based curriculum, training content, program metrics etc.
  • Ensure CAPA program effectiveness. Maintain the CAPA portfolio, governance board, program metrics etc.

Profile

  • Bachelor's Degree in a Sciences, Engineering or related discipline required, Master's degree preferred; or equivalent combination of education, training and experience.
  • 8+ years previous experience as a Quality professional supporting product development, product manufacturing, production and process control activities and Quality Systems support and maintenance required
  • Minimum of 5 years' experience managing and leading a team of professionals required.
  • Extensive experience and knowledge of FDA's Quality System Regulations, ISO 13485 and Medical Device Regulation required. Experience with other regulations is desired (Canada, Europe.)
  • ASQ Certifications are desirable (CQM, CQA, CQE etc.).
  • Six Sigma DMAIC experience and certification are highly desirable

Job Offer

  • Competitive base salary between $120,000-$150,000, depending on experience and skills
  • Yearly Bonus + Profit Sharing
  • Matching 401k
  • Benefits including, medical, dental, life, disability
  • 15 PTO Days + 9 holidays

Job Requirements

 

Apply