Quality Manager

Overview

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. 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, hiring of quality personnel, and establishes site-level policies to comply with Resonetics-wide directives. The Quality Manager is responsible for implementing new and revised corporate quality systems documents. The Quality Manager acts as the Resonetics site Management Representative and leads facilitation of external audits. The Quality Manager 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.

• Performs and supports the work using quality risk management principles and their application to medical device manufacturing.
• Liaises with customer quality personnel to resolve issues and customer complaints.
• Monitors and disseminates customer quality report cards.
• Generates process deviations, validation protocols, and reports.
• Generates customer change notices.
• Assists with troubleshooting of production and process development processes.
• Leads development of metrology equipment.
• Develops and maintains quality/control plans.
• Develops PFMECAs.
• Specifies metrology equipment.
• Conducts Gage R&R studies.
• Resolves corrective and preventive actions.
• Develops quality procedures and ensures training of personnel.
• Approves nonconformance disposition.
• Analyzes production and validation data.
• Works on continual improvement and process assessment projects as assigned.
• Supervises the quality department for the site.

• Minimum 8 years of 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.
• Proven experience leading the facilitation of external audits.
• Working knowledge of 21 CFR Part 820 and/or ISO 13485 compliance.
• Working knowledge of statistical software and/or Minitab.
• Bachelor’s degree or equivalent experience.
• Prior supervisory experience.

• Prior engineering management experience.
• CMQOE, CQE and/or Six Sigma Green or Black belt.
• Bachelor’s degree in engineering or science discipline.

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 $105,000 - $130,000.

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.