OverviewThe 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.
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.
Required 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.
Preferred Qualifications
- CMQOE, CQE and/or Six Sigma Green or Black belt.
- BS degree; Physics, Optics, Mechanical, Chemical, Plastics preferred.
- Experience with ISO 13485.
Physical Demands
- Position may include up to 10% domestic and international travel.
Compensation
The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $96,000-$142,000.
Our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.
