Provides customer- and factory-facing quality engineering support for medical device micro-manufacturing. Responsibilities include process validation, quality planning, PFMEA, risk documentation, metrology development, statistical analysis, nonconformance disposition, supplier and customer quality coordination, design control documentation, and continuous improvement. The role supports ISO 13485 and 21 CFR 820 compliance, product launches, process development, equipment calibration, and quality system training, with up to 10% domestic and international travel.
Overview
Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.
The Quality Engineer provides customer and factory facing quality support. The position includes managing the interface between Resonetics, its customers and suppliers quality organization, assisting with transition and sustaining of laser manufacturing processes, and support for our quality management system. The Quality Engineer position uses Quality Engineering techniques including: Problem solving using Lean Six Sigma methodology, Process Validations and Verifications, Process Development and optimization, Gage R&R, and reducing dependence on inspection along with ISO 13485 and/or 21CFR820 compliance.
Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.
Responsibilities- Monitoring and disseminating customer quality alerts and process deviations as required.
- Generating process deviations, Customer Change Notices, validation protocols & reports.
- Lead troubleshooting Quality opportunities during product launches and assisting with the Product Development Process.
- Leading development of metrology equipment
- Developing and maintaining quality/control plans and PFMEA.
- Ensuring Quality Management Systems procedures and appropriate regulations and industry standards are being utilized throughout the product development and process development processes.
- Developing Risk documentation in compliance with the QMS and regulatory standards, such as PFMECAs.
- Conducting Gage R&R studies and Design of Experiments
- Developing Quality Procedures and conducting training to all personnel as appropriate
- Approving Nonconformance disposition
- Analyzing production and validation data with advance statistic such as
- Anova & Regresion
- CPK, PPK & CP
- Control Charts
- SPC
- Gage R&R
- Design of Experiments
- Working on continual improvement and process assessment projects as assigned
- Author protocols or provides support in performing qualification validation protocols in support of design control deliverables.
- As a lead Quality Engineer on development projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for product builds.
- Support Equipment Calibration and Maintenance per the applicable procedures.
- Minimum 5 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
- Interact with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.
- Experience with databases and Business Intelligence (PowerBi, Tableau, etc)
- CQE and/or Six Sigma Green or Black belt
- BS degree; Physics, Optics, Mechanical, Chemical, Plastics, Engineering preferred.
- Strong attention to detail and satisfactory organizational skills.
- Able to self-manage project task
- Light office work only; position may include up to 10% domestic and international travel
- The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $70,304 - $102,000.
- For temp, temp-to-hire, and regular full-time positions, 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.
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