Quality Manager
About The Position
The Quality Manager provides customer- and factory-facing quality support for contract manufacturing of medical device components at a specific Resonetics site. 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. This role will act as the lead person for a manufacturing site for all Quality and Regulatory matters, and supervises other quality personnel on site. The Quality Manager position uses Quality Engineering techniques including: Problem solving using Lean Six Sigma methodology, Process Validations, Process Development and optimization, Gage R&R, reducing dependence on inspection, and ISO compliance.
Requirements
- 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.
Nice To Haves
- CMQOE, CQE and/or Six Sigma Green or Black belt.
- BS degree; Physics, Optics, Mechanical, Chemical, Plastics preferred.
- Experience with ISO 13485.
Responsibilities
- Liaising with customer quality personnel to resolve issues and Customer Complaints.
- Monitoring and disseminating customer quality report cards.
- Generating process deviations, validation protocols and reports.
- Generating Customer Change Notices.
- Assisting with troubleshooting of production and PDP processes.
- Leading development of metrology equipment.
- Developing and maintaining quality/control plans.
- Developing PFMECAs.
- Specifying metrology equipment.
- Conducting Gage R&R studies.
- Resolving Corrective and Preventive Actions.
- Developing Quality Procedures and ensure training of personnel.
- Approving Nonconformance disposition.
- Analyzing production and validation data.
- Working on continual improvement and process assessment projects as assigned.
- Supervising quality engineers, technicians, inspectors, and specialists on site.
Benefits
- Competitive compensation based on experience and qualifications.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
