Quality Manager

We’re a company of agile, customer-oriented individuals with a shared commitment to integrity, servant leadership, and teamwork. Our associates take pride and ownership in their work, and innovate to provide the highest quality, life-enhancing medical technology in the world. Together, We’re in It for Life.

The Quality Manager will be a key member of the Plant Leadership and responsible for all aspects of the quality systems process and serves as the site Quality leader & Management Representative. The Quality Manager will have 9-10 direct reports and oversight of quality team of 20 plus associates. The Orchard Park Site is in growth mode with nearly 250 associates across 2 buildings. The Quality Manager will report to the VP Quality Assurance and Regulatory Affairs.

Main Responsibilities: 

• Provide strategic leadership on all regulatory affairs and quality assurance programs and policies.
• Serve as the Management Representative of the quality system and be the interface with Notified Body’s and FDA
• Leading quality assurance team in the design, provision, and maintenance of systems for document and data change control, training, corrective and preventive action, discrepancy handling, product release, environmental monitoring, and complaint handling.
• Oversee the functional review and approval of quality system documentation.
• Collaborate with plant leadership to ensure adherence to documented processes and the development and attainment of key performance indicators.
• Interact with customers and suppliers on all quality matters.
• Direct the selection, training, and development of the quality team.
• Implement corrective action procedures and oversee internal/external audits and CAPA programs.

The successful candidate will possess:

• 5+ years of experience in a regulated industry (Medical - Aerospace- Automotive)
• 5+ years of Quality Managment leadership experience 
• Bachelor's degree required; Master’s degree in Engineering, Quality Management, or a related field preferred.
• Certified Quality Engineer (CQE) or Certified Manager of Quality/Organizational Excellence (CMQ/OE) is highly desirable.
• Extensive experience with FDA, ISO-13485, and other relevant regulations.
• Proven track record of successful regulatory audits and compliance.
• Demonstrated experience leading high-functioning teams and driving continuous improvement using Lean Six Sigma methodologies.
• Exceptional communication and interpersonal skills.
• Strong problem-solving abilities and decision-making skills.
• Results-oriented with a track record of achieving key performance indicators (KPIs).
• Experience within a contract manufacturing (Preferred)

Benefits: 

• Medical, dental, and vision benefits-effective on date of hire
• Generous paid time off benefits and 10 paid Holidays
• 3 weeks plus 2 days of PTO
• Company-paid life insurance
• 401k plan with company match
• Low-cost nutrition and mental health visits 
• Up to $150-off your gym membership annually 
• Discounted Pet Insurances for your furry friends
• Access to individualized financial planning meetings 
• Employee Discount Program with savings on electronics, home goods, gym equipment, and more
• Discounted family caregiving support
• Tuition Reimbursement 
• Defined Career Path for advancement in role and compensation 
• New Hire On-boarding Training Plans 

We offer market competitive compensation. Potential salary range for this role is $115k-$125k.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

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