Quality Manager

About the role

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. The Quality Manager provides customer- and factory-facing quality support for contract manufacturing of medical device components at a specific Resonetics site. This role 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 acts as the lead for all Quality and Regulatory matters at a manufacturing site and supervises other quality personnel on site. The position uses Quality Engineering techniques such as problem solving with 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 ensuring 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.

Requirements

• 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.

Pay

The compensation for this role is competitive and 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.