Quality Engineer

Now Hiring: Quality Engineer Location: North Haven, CT (Onsite) Experience Required: 8–10 Years (Medical Device Industry ONLY)

Job Summary:

We are seeking a highly skilled Quality Engineer with 8–10 years of experience in the medical device industry to support quality and validation activities at our North Haven, CT site. This role will be instrumental in ensuring product compliance, process optimization, and quality assurance throughout the manufacturing lifecycle.

Key Responsibilities:

Contribute to continuous improvement initiatives for product cost and quality.

Participate in DFM/DFA activities to align packaging and production processes.

Collaborate with Quality Engineering teams to support manufacturing operations.

Develop standardized work and process maps for production optimization.

Support line validation and qualification activities including IQ, OQ, MSA, and PQ .

Perform Root Cause Analysis (RCA) , NCR , and CAPA investigations and responses.

Conduct qualification, verification, and validation for medical device production.

Work with cross-functional teams to troubleshoot and resolve production issues.

Design, test, and validate processes and equipment, including process modeling.

Lead and execute PFMEA and validation activities in alignment with project goals.

Apply statistical tools like SPC , SQC , and DOE to improve processes.

Contribute to the Capital Expense Request (CER) process, including cost specifications for packaging and labeling equipment.

Manage documentation related to material disposition, process updates, NCRs, and CAPAs.

Conduct Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) .

Perform Validation Gap Analyses across multiple product families.

Initiate and manage CDPs related to validation efforts.

Ensure effective coordination and communication with key stakeholders.

Qualifications

• Bachelor’s Degree in Packaging Science, Mechanical Engineering , or related field (Master’s preferred).

• 8–10 years of experience in Quality Engineering within the medical device industry .

• Strong knowledge of mechanical/manufacturing engineering and industry standards.

• Experience with validation protocols , root cause analysis , process mapping , and cross-functional collaboration.