Quality Engineer

Client Torrington is seeking a hands-on results-driven Quality Engineer to support medical plastic injection molding and assembly operations. This role is responsible for ensuring the quality validation and regulatory compliance of new and existing medical products processes and equipment.
The position also serves as the Cleanroom Subject Matter Expert (SME) supporting cleanroom build-outs environmental monitoring and adherence to contamination control standards. The ideal candidate will have experience in process validation NPI product/equipment transfers and cleanroom operations within a regulated medical device environment.
Key Responsibilities
Quality Engineering & Assurance

• Develop implement and maintain quality assurance practices policies and documentation including Control Plans pFMEAs Inspection Plans SOPs and Validation Reports.
• Conduct audits of raw materials in-process components and finished goods to ensure compliance with quality standards.
• Schedule and coordinate inspection and quality resources to support projects NPI and validation activities.

• Lead and execute process and equipment validations (IQ/OQ/PQ) for new transferred or modified products molds and manufacturing equipment.
• Support machine mold and product transfers between lines or facilities ensuring validation scope documentation and regulatory compliance.
• Coordinate validation testing data collection statistical analysis and final reporting.
• Partner with Manufacturing Engineering Tooling and Program Management to ensure production readiness and long-term process capability.

• Serve as Cleanroom Subject Matter Expert (SME) for quality compliance and regulatory requirements.
• Support cleanroom design build-out and qualification ensuring alignment with product and process requirements.
• Lead cleanroom qualification and requalification activities (IQ/OQ/PQ) and establish environmental monitoring programs (particulates temperature humidity differential pressure).
• Review and trend environmental monitoring data; initiate investigations and CAPAs as needed.
• Develop and maintain cleanroom documentation including SOPs gowning procedures monitoring plans and risk assessments.
• Provide training on cleanroom behavior contamination control and gowning procedures to operators and staff.

• Ensure compliance with ISO 13485 FDA 21 CFR Part 820 GMP and customer-specific requirements.
• Support internal customer and regulatory audits maintaining traceable documentation for product launches and equipment integration.
• Participate in drawing reviews DFM assessments and design transfer to ensure quality requirements are achievable and measurable.

• Lead root cause investigations CAPAs and nonconformance resolution related to processes products and validation activities.
• Monitor production processes and quality data to identify trends and improvement opportunities.
• Drive continuous improvement initiatives to enhance process capability product quality and QMS effectiveness.
• Review process and product changes for potential QMS and validation impact.

• Support supplier qualification audits performance monitoring and corrective actions.
• Participate in new supplier evaluations and maintain theApproved Supplier List (ASL).
• Manage customer quality interactions including complaints RMAs corrective actions and routine status updates.

• Collaborate with Manufacturing Project Engineers and cross-functional teams to ensure seamless execution of product and equipment transfers.
• Provide quality input during design reviews process development and risk assessments.
• Mentor junior quality engineers and technicians and support operator training on quality and validated processes.

• Bachelors degree in Engineering (Mechanical Industrial Plastics or related discipline).

• 3-5 years of experience in Quality Engineering within medical device manufacturing preferably injection molding NPI and equipment integration.
• Experience supporting regulated environments cleanroom operations and process validation.

• Strong understanding of process validation (IQ/OQ/PQ) risk management and design transfer requirements.
• Familiarity with ISO 13485 FDA QSR GMP and other medical device standards.
• Knowledge of statistical tools (SPC MSA DOE) and quality management systems.
• Experience with injection molding processes and equipment.
• Excellent documentation technical writing analytical and project coordination skills.
• Strong verbal and written communication to collaborate across functions.

• ASQ Certified Quality Engineer (CQE) or equivalent.
• Cleanroom or contamination control training/certifications are a plus.

• Combination of office and manufacturing floor environment.
• Exposure to machinery noise moderate heat and typical plant conditions.
• Ability to stand or walk for extended periods; occasional lifting up to 25 lbs.
• Fast-paced deadline-driven collaborative environment.
• Up to 30% domestic travel for equipment integration validation or supplier support.
• Flexible hours may be required during validation execution launches or critical project phases.