Quality Manager
Resonetics
Summary
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 manufacturing processes, and support for supplier quality management.
Job description
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 oversees the site Quality department budget, Quality personnel hiring for the site, and establishes site-level policies to comply with Resonetics-wide directives.
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 department for a site.
- Responsible for facilitation of external and/or internal audits.
Required Qualifications
- 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
Preferred Qualifications
- CMQOE, CQE and/or Six Sigma Green or Black beltBS degree; Physics, Optics, Mechanical, Chemical, Plastics preferred
Physical Demands
- Position may include up to 10% domestic and international travel
Requirements
- 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
Company overview
Resonetics is a specialized medical device manufacturing company that focuses on precision manufacturing solutions for the healthcare industry. The company provides advanced manufacturing services including laser processing, micro-machining, and complex component fabrication for medical devices. Resonetics serves as a critical partner to medical device OEMs, offering expertise in materials science, engineering, and regulatory compliance. Their capabilities likely include the production of minimally invasive surgical instruments, implantable devices, diagnostic components, and other precision medical technologies. The company operates at the intersection of advanced manufacturing and medical innovation, delivering high-precision components that meet stringent quality standards required in the healthcare sector. With a focus on reliability and technical excellence, Resonetics plays an important role in the medical device supply chain, enabling the development and production of next-generation healthcare technologies that improve patient outcomes and advance medical science.