Quality Project Engineer

• Lead quality activities for new product introductions (NPI) and equipment integration projects.
• Support the integration of manufacturing equipment, ensuring proper setup, qualification, and validation.
• Develop, execute, and oversee validation protocols (IQ/OQ/PQ) for processes, molds, and equipment associated with new products or integrated equipment.
• Coordinate validation testing, data collection, and report generation.
• Partner with Manufacturing, Engineering, and Program Management teams to ensure readiness and compliance for product and process launches.

• Develop and maintain quality documentation:
  Control Plans, pFMEAs, Inspection Plans, SOPs, and Validation Reports.
• Conduct risk assessments and implement controls throughout new product launches and equipment integration.
• Verify product and process compliance with specifications, regulatory requirements, and quality standards.
• Conduct in-process and final audits to confirm successful implementation of integrated processes.

• Ensure all validation and integration activities comply with ISO 13485, FDA 21 CFR Part 820, GMP, and customer-specific requirements.
• Prepare and maintain documentation for audits and regulatory submissions.
• Maintain traceability of quality records related to new product launches and equipment integration.

• Lead root cause analysis and CAPAs for issues identified during validation or equipment integration activities.
• Identify opportunities to improve process capability, product quality, and documentation.
• Drive continuous improvement initiatives in quality systems and validation practices.

• Work closely with the Manufacturing Project Engineer and cross-functional teams to ensure seamless product and equipment integration execution.
• Provide quality input during design reviews, process development, and DFM assessments.
• Support customer communications regarding validation deliverables, integration progress, and quality outcomes.

• Create and maintain robust documentation including process flow diagrams, work instructions, SOPs, and validation protocols.
• Lead operator training and knowledge transfer for new or revised processes.

• Education:
  
  Bachelor's degree in Engineering (Mechanical, Industrial, Plastics, or related).
• Experience:
  
  3-5 years in Quality or Project Engineering roles within medical device manufacturing, preferably with injection molding, NPI, and equipment integration.
• Knowledge &
  
  Skills:
  
  Strong understanding of process validation, risk management, and design transfer requirements.
• Familiarity with ISO 13485, FDA, GMP, and other medical device standards.
• Knowledge of statistical tools (MSA, SPC, DOE) and quality management systems.
• Excellent documentation, technical writing, and project coordination skills.
• Strong communication skills to collaborate effectively across functions.

Certifications (Preferred): ASQ Certified Quality Engineer (CQE) or equivalent.

• Combination of office and manufacturing floor environments.
• 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 to support equipment integration and validations; flexible hours may be required.

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information or any other status protected by applicable laws or regulations.