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.
The Quality Manager also acts 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.
- 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.
- Minimum 8 years’ experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience
- Demonstrated technical writing and communication skills.
- Working knowledge of Statistical software and/or Minitab
- Bachelor’s degree or equivalent experience
- Prior supervisory experience
- CMQOE, CQE and/or Six Sigma Green or Black belt
- BS degree; Physics, Optics, Mechanical, Chemical, Plastics preferred
- Position may include up to 10% domestic and international travel
If qualified, apply now. Job title and job location must be included in the application.
To apply for this job, email your details, the job title and job location to firstname.lastname@example.org
Limitations and Disclaimer: The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.