Quality Manager
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Key skills for this role
Role Overview
Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry.
The Quality Manager provides customer- and factory-facing quality support for contract manufacturing of medical device components.
The role involves managing quality and regulatory matters, leading a team of quality personnel, and ensuring compliance with ISO standards.
The position includes managing the interface between Resonetics and customers’ supplier quality organization, assisting with transition and sustaining of laser micromanufacturing processes, and support for supplier quality management.
Key Skills for This Role
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About Resonetics and the Role
Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry.
The Quality Manager provides customer- and factory-facing quality support for contract manufacturing of medical device components.
The role involves managing quality and regulatory matters, leading a team of quality personnel, and ensuring compliance with ISO standards.
The position includes managing the interface between Resonetics and customers’ supplier quality organization, assisting with transition and sustaining of laser micromanufacturing processes, and support for supplier quality management.
Responsibilities
- Liaise with customer quality personnel to resolve issues and Customer Complaints.
- Monitor and disseminate customer quality report cards.
- Generate process deviations, validation protocols and reports.
- Generate Customer Change Notices.
- Assist with troubleshooting of production and PDP processes.
- Lead development of metrology equipment.
- Develop and maintain quality/control plans.
- Develop PFMECAs.
- Specify metrology equipment.
- Conduct Gage R&R studies.
- Resolve Corrective and Preventive Actions.
- Develop Quality Procedures and ensure training of personnel.
Qualifications
- 8+ years’ experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience.
- Strong experience leading a team of Quality Engineers.
- Previous experience leading Audits.
- Demonstrated technical writing and communication skills.
- Working knowledge of Statistical software and/or Minitab.
- Bachelor’s degree or equivalent experience.
- CMQOE, CQE and/or Six Sigma Green or Black belt.
- BS degree; Physics, Optics, Mechanical, Chemical, Plastics preferred.
- Experience with ISO 13485.
- Up to 10% domestic and international travel.
Compensation and Benefits
- Competitive salary based on experience and qualifications.
- The anticipated range is $96,000-$142,000.
- The company does not provide visa sponsorship.
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