The Quality Engineer provides customer- and factory-facing quality support for contract manufacturing of medical device components. 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 Engineer 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, ISO 13485 and/or 21CFR820 compliance.
- Liaising with customer quality personnel to resolve issues and Customer Complaints
- Monitoring and disseminating customer quality report cards
- Generating process deviations, Customer Change Notices, validation protocols & reports.
- Assisting with troubleshooting of production processes Assisting with the PDP process
- Leading development of metrology equipment
- Developing and maintaining quality/control plans
- Developing PFMECAs
- Conducting Gage R&R studies
- Resolving Corrective and Preventive Actions
- Developing Quality Procedures and conducting training to all personnel as appropriate
- Approving Nonconformance disposition
- Analyzing production and validation data
- Working on continual improvement and process assessment projects as
- Minimum 2 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
- CQE and/or Six Sigma Green or Black belt
- BS degree; Physics, Optics, Mechanical, Chemical, Plastics preferred
- Light office work only; position may include up to 10% domestic and international travel
If qualified, send resume to
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.