Advanced Orthopedic Device Quality Assurance Specialist

We are seeking a seasoned quality assurance specialist to ensure the highest standards of quality and compliance in our innovative orthopedic medical devices. This role plays a pivotal part in establishing and maintaining robust quality management systems (QMS) and regulatory strategies to support product development, clinical trials, and manufacturing processes.

• Quality Assurance and Control:
  • Develop, implement, and maintain a Quality Management System (QMS) compliant with FDA QSR, ISO 13485, and EU MDR regulations.
  • Conduct risk assessments and failure mode and effects analysis (FMEA) to identify and mitigate potential issues in orthopedic device design and manufacturing.
  • Oversee validation and verification of manufacturing processes and equipment, ensuring design for manufacturability and product reliability.
  • Perform quality control inspections, reviewing specifications for raw materials, intermediate products, and finished orthopedic devices.
  • Manage non-conformance investigations, root cause analysis, and corrective and preventive actions (CAPA) to address defects and ensure product safety.
• Regulatory Compliance:
  • Interpret and ensure compliance with U.S., EU, and international regulatory requirements for orthopedic medical devices.
  • Support regulatory submissions, including 510(k), PMA, and CE marking, by preparing documentation and interfacing with regulatory authorities.
  • Facilitate post-market surveillance, including complaint investigations, trending complaint data, managing recalls, and medical device reporting to regulatory bodies.
  • Coordinate internal and external audits, ensuring readiness for regulatory inspections and supplier evaluations.
• Cross-Functional Collaboration:
  • Collaborate with R&D, engineering, and clinical development teams to integrate quality and regulatory requirements into the product development lifecycle.
  • Work with suppliers to evaluate and certify their capabilities, ensuring compliance with quality standards for materials used in orthopedic implants and devices.
  • Provide regulatory guidance and training to internal teams to align with current standards and industry trends.
• Continuous Improvement:
  • Lead initiatives to reduce product recalls, defects, and associated costs by implementing effective QA processes.
  • Monitor and update quality and regulatory documentation, including Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR).

Qualifications:

• Bachelor's or Master's degree in engineering, biology, chemistry, or a related technical field.
• Minimum of 8 years of experience in quality engineering or regulatory affairs within the medical device industry, preferably with orthopedic devices.
• Hands-on experience with FDA QSR, ISO 13485, ISO 14971, and EU MDR regulations.
• Experience with orthopedic trauma implants is a plus.
• ASQ Certified Quality Engineer (CQE) or similar certification preferred.

Skills:

• Strong understanding of statistical process control, design of experiments, and quality management tools.
• Proficiency in developing and documenting manufacturing protocols and quality records.
• Excellent communication skills for interfacing with cross-functional teams, suppliers, and regulatory authorities.
• Detail-oriented, self-directed, and able to manage multiple projects under tight deadlines.

Additional Requirements:

• Ability to travel occasionally to suppliers or manufacturing sites.
• Familiarity with biocompatibility, sterilization, and product labeling requirements for orthopedic devices.
• Prior experience supporting regulatory submissions for orthopedic devices.

Why Join Us:

• Be part of a fast-paced, innovative team advancing global orthopedic solutions that improve patient outcomes.
• Competitive salary and comprehensive benefits package.
• Opportunities for career growth and professional development.