Quality Assurance Manager

Full-time Quality Manager needed in Bethel, CT, excellent benefits day one

The Quality Manager provides customer- and factory-facing quality support for contract manufacturing of medical device components. The position includes managing the interface between Company 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, Quality personnel hiring for the site, and establishes site-level policies to comply with company-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.

Qualifications:

Minimum 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