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Quality Manager- Medical Devices- Buffalo, NY

Buffalo, New York Permanent USD100,000 - USD125,000 per year View Job Description
The Quality Manager (Medical Devices) will lead a dynamic team in a growing medical technology facility, overseeing all quality systems and ensuring compliance with FDA and ISO-13485 standards. This role combines strategic leadership and hands-on management to drive continuous improvement, support regulatory readiness, and foster a culture of operational excellence at the Buffalo, NY facility.
  • Competitive Salary and Strong Benefits Plan
  • Ability to Drive Impactful Change Within the Organization

About Our Client

My client is a growing manufacturer in the medical technology industry, focused on delivering innovative, life-enhancing solutions. With a culture centered on integrity, teamwork, and continuous improvement, the company empowers its employees to take ownership and drive meaningful impact.

The facility operates across multiple buildings and plays a key role in the organization's broader growth strategy. Known for its strong focus on quality and regulatory compliance, the company values cross-functional collaboration and lean principles to ensure efficiency and high product standards. This is an ideal setting for engineers who are driven by purpose and enjoy leading in a dynamic, technical environment.

Job Description

The Quality Manager (Medical Devices) will:



  • Serve as the site Quality leader and Management Representative, ensuring compliance with FDA, ISO-13485, and other applicable regulations.


  • Lead and develop a quality team of 20+ associates, including 9-10 direct reports.


  • Oversee all aspects of the quality management system, including document control, CAPA, training, audits, and product release.


  • Act as primary liaison with regulatory bodies, customers, and suppliers on quality-related matters.


  • Drive continuous improvement initiatives using Lean Six Sigma and root cause analysis methodologies.


  • Ensure readiness for and successful execution of internal and external audits.


  • Collaborate with plant leadership to define and achieve key quality performance metrics.


  • Direct the implementation and monitoring of corrective and preventive actions.


  • Guide the development and maintenance of complaint handling and discrepancy resolution processes.


  • Review and approve quality system documentation and changes.


  • Provide strategic input to align quality systems with business growth and operational goals.


  • Support training and career development across the quality function to build team capabilities.

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 successful applicant will have:



  • 5+ years of quality leadership experience in a regulated industry (medical device, aerospace, or automotive preferred).


  • Proven track record managing quality systems in compliance with FDA, ISO-13485, and related standards.


  • Bachelor's degree required; advanced degree in engineering, quality, or related field preferred.


  • Experience leading regulatory inspections and successful audit outcomes.


  • Demonstrated ability to lead and develop high-performing quality teams.


  • Strong knowledge of CAPA, internal audits, complaint handling, and document control.


  • Certified Quality Engineer (CQE) or Certified Manager of Quality/Organizational Excellence (CMQ/OE) preferred.


  • Familiarity with Lean, Six Sigma, or other continuous improvement methodologies.


  • Effective communicator with strong interpersonal and leadership skills.


  • Skilled in cross-functional collaboration and influencing at multiple organizational levels.


  • Data-driven decision maker with strong analytical and problem-solving skills.


  • Experience in a contract manufacturing environment.



If interested please aply through the link below. Qualified applicants will be contacted within two bsuiness days.

What's on Offer



  • Competitive base salary and bonus potential up to 12%


  • Comprehensive health benefits starting on day one (medical, dental, vision)


  • 401k match of 3%


  • Company-paid life insurance and additional voluntary coverage options


  • Support for professional development through training and tuition reimbursement


  • Career progression opportunities with a clearly defined advancement path


  • Access to wellness resources, including fitness discounts and holistic health support


  • Financial planning assistance and employee discount programs


  • Family-friendly benefits, including caregiving support and pet insurance options


  • Structured onboarding and mentorship for new hires


  • Dynamic, growth-oriented work environment with strong leadership support



Contact
Erica Carney
Quote job ref
JN-052025-6736652

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Industrial / Manufacturing
Location
Buffalo
Contract Type
Permanent
Consultant name
Erica Carney
Job Reference
JN-052025-6736652