Quality Assurance Manager

Full-time Quality Manager needed in Bethel, CT, excellent benefits day oneThe 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 qualitymanagement.

If the following job requirements and experience match your skills, please ensure you apply promptly.
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 ComplaintsMonitoring and disseminating customer quality report cardsGenerating process deviations, validation protocols and reportsGenerating Customer Change NoticesAssisting with troubleshooting of production and PDP processesLeading development of metrology equipmentDeveloping and maintaining quality/control plansDeveloping PFMECAsSpecifying metrology equipmentConducting Gage R&R studiesResolving Corrective and Preventive ActionsDeveloping Quality Procedures and ensure training of personnelApproving Nonconformance dispositionAnalyzing production and validation dataWorking on continual improvement and process assessment projects as assignedSupervising quality department for a site.Responsible for facilitation of external and/or internal audits. xzbcwsv
Qualifications:Minimum 8 years’ experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experienceDemonstrated technical writing and communication skills.Working knowledge of Statistical software and/or MinitabBachelor’s degree or equivalent experiencePrior supervisory experience