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
Quality Assurance Manager in bethel at Unknown Company
This position is listed as contract and onsite.