Senior Quality Manager

Leominster, Massachusetts Permanent USD130,000 - USD165,000 per year View Job Description
We are seeking a Senior Quality Manager to lead site-wide quality systems, regulatory compliance, and continuous improvement initiatives within a highly regulated manufacturing environment. This individual will partner closely with operational leadership to strengthen quality performance, oversee audits and compliance programs, and drive strategic quality initiatives that support business growth.
  • Lead enterprise quality strategy in a high-growth medical device environment
  • Drive continuous improvement and regulatory excellence with executive impact

About Our Client

Our client is an industry-leading advanced manufacturing organization recognized for delivering highly engineered products to demanding and regulated markets. The company promotes a culture of innovation, operational excellence, and employee engagement while investing heavily in quality, technology, and continuous improvement

Job Description

  • Lead the development, implementation, and continuous improvement of the Quality Management System (QMS).
  • Establish quality goals, policies, and procedures aligned with site and enterprise objectives.
  • Partner with cross-functional leaders to promote a culture of quality and compliance throughout the organization.
  • Serve as the quality lead on strategic projects, providing guidance on timelines, risk mitigation, and quality requirements.
  • Manage internal audit programs and oversee corrective actions resulting from customer, regulatory, and certification audits.
  • Present quality performance metrics, compliance findings, and improvement recommendations to executive leadership.
  • Oversee CAPA, complaint handling, quality investigations, and other critical quality system processes.
  • Facilitate Management Review activities and support continuous improvement initiatives across operations.
  • Lead implementation of quality improvement methodologies including SPC, FMEA, root cause analysis, and Six Sigma tools.
  • Manage inspection, calibration, metrology, and measurement system programs to ensure accuracy and compliance.
  • Act as the primary quality contact during customer audits, external assessments, and regulatory inspections.
  • Analyze quality trends and operational metrics to identify improvement opportunities and reduce risk.
  • Lead risk management activities for products and manufacturing processes.
  • Oversee customer complaint investigations and ensure timely resolution through effective CAPA execution.
  • Support validation, FAI reporting, capability studies, and measurement system analysis activities.
  • Recruit, mentor, and develop high-performing quality professionals.



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

  • Bachelor's degree in Engineering, Quality, Applied Science, Business, or a related technical discipline.
  • Experience in a CMO (Contract Manufacturing Organization)
  • Experience with Thermoplastic Injection Molding
  • 5+ years of quality management experience or 10+ years of progressive quality assurance/quality control leadership experience.
  • Manufacturing industry experience required; medical device experience strongly preferred.
  • Strong knowledge of FDA regulations, ISO 13485, ISO 14971, EU MDR, and related quality standards.
  • Experience managing CAPA systems, internal audits, complaint handling, risk management, and validation activities.
  • Expertise in APQP, control plans, metrology, MSA, FAI, capability studies, and statistical quality methodologies.
  • Proven success leading continuous improvement and structured problem-solving initiatives.
  • Strong leadership, communication, and stakeholder management skills.
  • Ability to influence cross-functional teams and executive-level decision makers.
  • ASQ certifications such as CMQ/OE, CQE, or CQA are highly preferred.

What's on Offer

  • Competitive salary ranging from $130,000 to $165,000 annually.
  • Opportunity to shape and elevate the organization's quality strategy.
  • High-visibility leadership role with direct interaction with executive leadership.
  • Significant influence on operational performance and business outcomes.
  • Lead meaningful continuous improvement and compliance initiatives.
  • Join a company that values innovation, professional growth, and employee engagement
Contact
Kyle Perry
Quote job ref
JN-092026-7115946

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Healthcare / Pharmaceutical
Where
Leominster
Contract Type
Permanent
Consultant name
Kyle Perry
Job Reference
JN-092026-7115946
 

Michael Page is an inclusive employer. We want to make sure you have everything you need to perform at your best throughout our hiring process, so please let us know if there is anything we can do to support with your application or interview.