Job Description

Job Title: Quality Assurance Engineer
Location: North Haven, CT (100% Onsite)

Experience: 6+ years
Duration: 12+ Months Contract

About the Role

We are seeking a Quality Assurance Engineer to join our Surgical Instruments team, supporting new product development. This role partners with cross-functional teams to ensure product quality, compliance, and continuous improvement. The ideal candidate brings expertise in mechanical and electromechanical design, design verification/validation, process validation, risk management, and complaint analysis within a regulated environment.

Key Responsibilities

• Actively participate in product development by reviewing design documentation, performing risk assessments, and defining verification and validation testing requirements.

• Drive product risk assessments through tools such as risk management plans/reports, hazard identification, risk analysis charts, and complaint analysis.

• Collect, analyze, and interpret statistical data; prepare reports and recommendations for management.

• Support design and process validation initiatives, including oversight of system/sub-system requirements, CTQ matrix, process flows, control plans, MSA, and process capability analyses.

• Ensure consistent use of quality engineering tools across projects.

• Develop and implement solutions for complex engineering challenges aligned with organizational objectives.

Required Qualifications

• Bachelor's degree in Engineering, Math, Physical Science, or related field.

• 5+ years of experience in engineering or quality (or 4+ years with Master's degree).

• Experience in a regulated industry (medical devices preferred).

• Strong foundation in electro-mechanical design and manufacturing processes.

• Proficiency with statistical analysis tools (e.g., Minitab).

• Experience with risk management tools and methodologies.

• Excellent organizational, analytical, and problem-solving skills.

• Ability to work independently and in a team environment, balancing multiple projects.

• Strong written and verbal communication skills.

Preferred Qualifications

• 6+ years of experience in a regulated industry (advanced degree may substitute for 2 years).

• ASQ Certified Quality Engineer (CQE).

• Knowledge of medical device regulations and standards, including FDA QSR, ISO 13485, ISO 14971, and IEC 60601.

• Experience with software/hardware interfaces.

• Strong project management skills with the ability to prioritize effectively.

Job Tags

Contract work,

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