Quality And Regulatory Manager - Medical Device - Woburn

Woburn Permanent USD120,000 - USD160,000
  • Run the Quality Department at a Hands-On Manufacturer specializing in ISO13485
  • High visibility position with an organization that promotes internal growth

About Our Client

Our client is the market leading provider of manufacturing solutions for complex, high-precision products for the Medical Device and Aerospace markets. With unparalleled experience in high-precision manufacturing, our client provides a wide spectrum of Manufacturing Solutions and Services

Job Description

The Senior Quality Manager will be responsible for:

  • Oversee and implement an advanced level of world-class quality systems for planning, design of experiments, ISO 13485, AS9100, quality function development, design for world-class manufacturability.
  • Take a leadership role as a Sr. Manager and mentor supporting functional team members.
  • Integrate the quality function with manufacturing as a value added (real-time) support function, optimizing the continuous quality improvement process, while reducing cost and improving customer relationships.
  • Design and facilitate the development of quality systems for a highly regulated medical device industry to achieve customer satisfaction, increase productivity and maximize the profit margins. The objective is to devise systems that facilitate good products fast without compromise.
  • Enhance the one company systems interface capabilities, whereas optimizing the capabilities to perpetuate harmonized systems improvements, and based on deploying the best practices from the collective experience contribution of the worldwide teams.
  • Ensure the quality systems focus remains on continual quality improvement, while aligned with internal and external customer expectations. The results/objectives are geared on achieving an error-free (flawless) process, which will deliver products on time with world-class quality standards for improving quality, profits and generating new business.
  • Ensure the organization is basing improvement related decisions on factually/meaningful data, subsequently reducing waste and expediting the recognition of favorable results.
  • Leadership responsibility for promoting and developing the following ; Worldwide Quality Management Systems Software implementation/validation and harmonization (ETQ); New Product Development; and Supplier Quality Systems.



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.

The Successful Applicant

The Senior Quality Manager should bring the following to the table: Educational/Training Requirement:

  • Bachelor of Science in Engineering
  • ISO 13485 and AS 9100 experience



Experience:

  • 10+ years of Quality Engineering experience within a manufacturing environment required.
  • Minimum of 2 years of experience related to working within a regulated environment is preferred.



Licenses/Certifications:

  • Six Sigma Black Belt certification (desirable but not essential)
  • ASQ: CBA, CQA and CQE certification, preferred.

What's on Offer

The Senior Quality Manager will be compensated:

  • Very competitive base salary and bonus structure
  • Competitive benefits
  • Extremely fast upwards mobility and high visibility



Please reach out to Cameron Cyker with any questions, and apply below today!

Contact
Cameron Cyker
Quote job ref
JN-052022-5592881

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Six Sigma, Lean, Process improvement
Industry
Industrial / Manufacturing
Location
Woburn
Contract Type
Permanent
Consultant name
Cameron Cyker
Job Reference
JN-052022-5592881