Website Agile Workplace Staffing

Agile is looking for a Quality Engineering Manager in Burlington MA

Job Summary

As Quality Manager, he/she will perform tasks that will uphold and improve the product quality of the medical devices manufactured and meet regulatory requirements to stay in compliance.

What you will be doing:

  1. Formulates and maintains quality objectives (goals) complementary to corporate policies and goals of building high quality medical devices.
  2. Reads and Interpret Standards in biology, chemistry, microbiology, sterilization and mechanical product testing for Standard Operating Procedures and Protocol creation supporting the manufacturing and release of Medical Devices. 
  3. Reviews and approves the technical information within protocols and reports generated by the engineers and outside laboratories
  4. Review suppliers performance by reviewing  inspection (mechanical) and testing (chemistry/microbiology) results for chemicals, plastics and metal components
  5. Develops strategies and plans for medical device and process corrections and corrective actions with design and process improvements.
  6. Plays an active role in reducing costs (i.e. scrap) and increasing efficiencies within the department.
  7. Gathers data for the development of a departmental budget
  8. Gathers QMS metrics and reports this information to the Engineers in the form of a power point presentation
  9. Directly supervises 2-4 employees in the Quality Department. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

What we require from you:

  1. Bachelor’s Degree in or Medical Science such as Biology, Chemistry, Pharmacy or closely related discipline
  2. A minimum of 6 years related experience in medical device or pharmaceutical industries
  3. A minimum of 5 years related experience Quality Engineering or other Medical Device engineering functions
  4. Prior People Management experience

We are Committed to Your Success

We offer a competitive package, dynamic work environment, collaborative team, and space to learn, grow and thrive. Qualified applicants will receive consideration regarding race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, veteran status, or disabilities.

If you are a hardworking, driven professional looking for your next team. We are committed to employing a diverse workforce,  let’s start a conversation. Apply today!  



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