Manufacturing Quality Manager – Medical Device

Job ID 3897

Manufacturing Quality Manager – Medical Device

Location: Mt. Vernon NY area

Join a Growing Global Medical Device Leader!

Our client, an innovative and fast-growing medical device company, is seeking a Manufacturing Quality Manager to lead quality initiatives and help drive the next stage of their success. This is a high-impact role with significant growth potential, offering the opportunity to shape product quality, improve processes, and ensure compliance across global operations.

As the Manufacturing Quality Manager, you’ll oversee product quality assurance, quality system management, and manufacturing process excellence—while playing a key role in resolving customer issues and advancing continuous improvement efforts. You’ll report directly to the International Director of Quality and collaborate with teams across manufacturing, engineering, and regulatory to uphold the highest standards of product safety and performance.

This position supports compliance with FDA, ISO 13485, and international regulatory standards (EU, Canada, Brazil, Japan, and more), ensuring quality systems and operations align with global best practices.

Responsibilities:

• Maintain 510(k)s, DHFs, DHRs/DMRs, and validation records per FDA, ISO 13485, and global regulations.
• Support Manufacturing and R&D in risk management, qualification, and validation.
• Improve processes and systems to ensure cGMP and ISO 13485 compliance.
• Champion quality goals, policies, and regulatory adherence.
• Lead CAPA and problem-solving to prevent and resolve quality issues.
• Track corrective action effectiveness and drive continuous improvement.
• Develop QC plans, sampling systems, and statistical controls.
• Manage supplier quality, audits, and performance.
• Conduct internal, customer, and ISO audits per FDA/ISO requirements.
• Review and approve validation protocols, reports, and reliability data.
• Perform process capability studies and implement quality enhancements.
• Maintain and communicate accurate project schedules.

Requirements:

• BS in Engineering preferred; other technical or science degrees considered
• 3 years of Quality experience in Manufacturing Operations
• In-depth knowledge of GMP, Quality Systems, Regulatory Requirements, Validation, and Manufacturing in a medical device environment
• Experience with FDA, ISO, and/or TS Quality Systems
• Strong understanding of manufacturing inputs/outputs, materials, waste, cost control, and process optimization
• Proven project management and multitasking skills
• Skilled in interpreting technical/scientific publications and regulatory documents; capable of writing reports and procedures and presenting to senior leadership or regulatory bodies
• ASQ Quality Auditor/Engineer, PE, or Lean Six Sigma certification highly desirable

Targeted Salary:

$100k to $115k plus bonus with solid benefits package.

Ready to take the next step in your quality leadership career?

Join a company where your expertise will make a measurable impact—apply or reach out today to learn more at: dave@morisey-dart.com