Quality Manager at Ametek, Inc. in Holyoke, Massachusetts

Job Description:

Paragon Medical is a leading partner in medical device manufacturing, providing comprehensive supply chain solutions from concept to delivery. With expertise in implants, surgical instrumentation, and disposable devices, we offer tailored solutions to exceed customer expectations.

Job Summary: Responsible for ensuring the production of high-quality medical devices, from order receipt to shipment and documentation. Develops and implements internal systems to meet customer, ISO 13485, and FDA 820/GMP requirements.

Key Responsibilities:

• Build, manage, and lead a team of technical quality associates.
• Develop training programs and provide instruction on quality and process tools.
• Support the development and maintenance of a quality system meeting ISO and FDA requirements.
• Drive continuous improvement initiatives through data analysis and corrective action implementation.
• Supervise quality engineers and inspection processes.
• Ensure compliance with FDA and customer guidelines.
• Participate in internal and external audits.
• Lead Six Sigma and lean manufacturing projects.
• Provide budget inputs and track costs.
• Review and implement corrective actions based on customer performance metrics.
• Maintain validated processes and oversee calibration of monitoring devices.
• Develop product-specific Inspection and Control Plans.
• Lead project implementations for Process Flow, Quality Systems, and Statistical Process Controls.
• Work directly with customers on Dock to Stock programs.
• Manage factory metric boards and Quality Council.
• Develop and implement actions to meet corporate Quality and Delivery objectives.
• Manage the calibration process.
• Provide occasional production assistance and technical guidance.
• Participate in external audits and regulatory affairs.

• Minimum Bachelor's Degree, preferably in mathematics, statistics, or industrial practices.
• 7+ years of equivalent Quality Management or Quality Engineering experience. ASQC certifications may be considered in lieu of a degree.

• Excellent interpersonal and communication skills.
• Proficiency in statistical process control techniques.
• Self-motivated and able to work with minimal supervision.

• Sitting, standing, walking, grasping, climbing, stooping, kneeling, or crawling as required.
• Occasional lifting, carrying, pushing, and pulling up to 10lbs.

• Office environment with low noise levels.

Compensation

Salary Minimum: Market

Salary Maximum: Market

Incentive:

Disclaimer: Where a specific pay range is noted, it is a good faith estimate at the time of this posting. The actual salary offered will be based on experience, skills, qualifications, market / business considerations, and geographic location.

AMETEK, Inc. is a leading global provider of industrial technology solutions serving a diverse set of attractive niche markets with annual sales over $7.0 billion.

AMETEK is committed to making a safer, sustainable, and more productive world a reality. We use differentiated technology solutions to solve our customers' most complex challenges. We employ 21,000 colleagues, in 35 countries, that are grounded by our core values: Ethics and Integrity, Respect for the Individual, Inclusion, Teamwork, and Social Responsibility. AMETEK (NYSE:AME) is a component of the S&P 500. Visit www.ametek.com for more information.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 1 (866) 263-8359.

Nearest Major Market: Springfield MA