Quality Engineer

Position Overview

This role supports the company's global product portfolio by maintaining registration status throughout product lifecycles, championing key functions of the Quality Management System, and executing supplier qualification and performance activities. The Quality Engineer serves as a liaison between internal teams, external customers, and suppliers — building strong relationships and ensuring quality standards are upheld across all areas of responsibility.

Key Responsibilities

Risk Analysis

• Oversee the risk management process per ISO 14971, including review and approval of risk management files for new product development and ongoing maintenance for post-commercialization products and acquisitions
• Apply quality tools such as cause and effect diagrams, flowcharts, Pareto charts, and root cause analysis methodologies
• Review and approve design control, manufacturing, quality, engineering, and validation documentation for conformance to procedures and risk management requirements
• Review product labeling for technical accuracy, alignment with the device risk profile, and compliance with US and international regulatory standards

QMS Maintenance

• Review sterilization records including monitoring logs, acceptance activity records, and sterilization certifications to verify operational and performance parameters
• Evaluate engineering change orders and collaborate with cross-functional teams to assess and manage changes that could impact quality risk
• Actively participate in formal design reviews and design transfer activities to ensure adherence to product development processes and design control procedures
• Support the preventative maintenance and calibration program, including management of the master validation plan for products and software
• Maintain and remediate technical documentation to current state-of-the-art standards as required
• Analyze quality data and provide practical, compliant guidance in support of regulatory activities, agency responses, quality KPIs, and improvement initiatives
• Participate in internal and external audits and regulatory inspections across global sites

Process Specifications & Validations

• Maintain process specifications and sterilization validations with contract sterilizers, including periodic reviews, revalidations, and product testing
• Support software validations, maintenance activities, and requalification efforts
• Develop product specifications, inspection plans, and test methods aligned with procedural and contract manufacturing requirements including ANSI sampling methodology
• Develop laboratory test procedures and oversee or execute test method validation and testing activities

CAPA & Nonconformance

• Identify and escalate opportunities for corrective and preventive action; support investigation, resolution, and effectiveness confirmation
• Manage quality complaint investigations and resolve CAPAs within areas of responsibility
• Oversee technical sample reviews for complaint and nonconforming product samples

Supplier Quality

• Support the supplier quality program including supplier validation, verification, qualification, and ongoing performance monitoring
• Serve as the primary organizational contact for specific supplier projects and initiatives
• Troubleshoot technical issues related to design, development, and manufacturing in support of complaints, CAPAs, and supplier corrective action requests
• Develop and manage qualifications of specific products with new or existing suppliers

Qualifications

Required:

• Bachelor's degree required; degree in Engineering strongly preferred
• Prior experience in the medical device industry
• Working knowledge of ISO 13485 and 21 CFR 820
• Strong analytical, problem-solving, and technical writing skills
• Experience with statistical analysis and associated software tools
• Ability to work independently and as part of a cross-functional team
• Strong project management and organizational capabilities

Preferred:

• Certified Quality Engineer (CQE) and/or Certified Reliability Engineer (CRE)
• Lean Six Sigma Green Belt or Black Belt
• Certified Project Manager
• Knowledge of terminal sterilization processes (EO, Gamma, I-Beam) including validation methodologies

Equal Opportunity Statement

This employer is committed to building a diverse and inclusive team. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, or local law.