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Quality Engineer

6 hours ago

Torrington, Connecticut, United States Aptyx Full time

Aptyx 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.

Process Validation & Product/Equipment Transfer

  • 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.

Cleanroom SME & Environmental Compliance

  • 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.

Regulatory Compliance & Audits

  • 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.

Problem Solving & Continuous Improvement

  • 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.

Supplier & Customer Quality Support

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

Cross-Functional Collaboration & Training

  • 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.

Qualifications

Education

  • Bachelor's degree in Engineering (Mechanical, Industrial, Plastics, or related discipline).

Experience

  • 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.

Knowledge & Skills

  • 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.

Certifications (Preferred)

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

Work Environment & Physical Requirements

  • 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.