Quality Engineer

Defibtech is seeking a Quality Engineer based at our manufacturing site in Branford, CT, responsible for supporting product and process quality for a medical device company in support of class III devices in a cGMP environment. The Quality Engineer will partner cross-functionally to implement quality engineering initiatives supporting manufacturing and supplier activities across all product lines in support of Defibtechs mission to provide high-quality medical devices.

• Applies knowledge of

• Performs data trending for Defibtech (Nonconforming material reports) to identify potential CAPA/SCARs from nonconformance trending.
• Supports in production investigations as it pertains to nonconformances, potential supplier issues, design issues, including risk assessment and potential for fielded product impact.
• Represents the Quality function in various roles such as supplier quality, supplier audits, and supplier Quality Agreements.
• Interfaces with Suppliers as needed to monitor process controls and metrics for continuous improvement opportunities, trending potential defects, and product changes.
• Provides quality input in assisting with generating Process Qualification plans, reviewing process inputs, outputs, verification, validation, phase reviews and/or scale up strategies.
• Supports employees in understanding applicable Quality Engineering methodologies and Quality System Processes relating to Quality Engineering.
• Supports review Incoming Inspection drawings and inspection forms, First Article Inspections (FAIs) for new and existing components.
• Assists in the development and maintenance of company procedures for process control, process validation and related areas of the quality management system.
• Supports internal and external audits.
• Demonstrates Defibtechs values on the job by focusing actions on Integrity, Passion, Ownership, and Innovation. Promotes and participates in continuous improvement.
• Actively supports compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, safety regulations and applicable statutes).

• Bachelors Degree with at least 2 years of related work experience or the equivalent combination of education, experience, and/or training.
• Preferred candidates will have a bachelors degree in an engineering discipline and 3+ years of experience.
• A minimum of 2 years in quality within the medical device industry is required.
• ASQ (e.g., CQE, CMQ/OE, etc.) and/or Lean and/or Six Sigma certification is highly preferred.

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