Quality Assurance Manager

JVT Advisors; Bethel (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

JVT Advisors is seeking a Full-time Quality Manager in Bethel, CT to lead the site quality and regulatory program for contract manufacturing of medical device components. You will supervise the site Quality department, manage budgets, and develop site-level policies aligned with company directives.

You will apply Lean Six Sigma, drive process validations and metrology development, and coordinate with customer supplier quality teams to ensure compliant, quality outcomes across manufacturing and

Qualifications

• 8+ years in quality engineering for medical devices or equivalent.
• Strong technical writing and communication skills.
• Proficiency with statistical software and Minitab.
• Bachelor's degree or equivalent experience.

Responsibilities

• Liaise with customer quality personnel to resolve issues and complaints.
• Monitor and disseminate customer quality scorecards.
• Generate deviation, validation protocols, and reports.
• Lead development of metrology equipment.
• Develop and maintain quality/control plans.
• Oversee site quality audits and CAPA processes.
• Facilitate external and internal audits.
• Drive continual improvement and process assessment.

Skills

Quality Engineering

Lean Six Sigma

Statistical software

Minitab

Technical writing

Communication skills

Education

Bachelor's degree

Job description

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
• 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