Quality Engineer / Regulatory Specialist - Reno, NV and/or Singapore

Key Responsibilities:

• Quality Assurance and Control:
• Develop, implement, and maintain a Quality Management System (QMS) compliant with FDA Quality System Regulation (QSR, 21 CFR 820), ISO 13485:2016, and EU MDR 2017/745.
• Conduct risk assessments (e.g., dFMEA, pFMEA) 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 per engineering drawings and SOPs.
• 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. (FDA), EU (MDR), 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 (e.g., FDA, MHRA).
• 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, from prototyping to commercialization.
• 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:

• Education: Bachelor’s or Master’s degree in engineering (Mechanical, Biomedical, or related), Biology, Chemistry, or a related technical field.

• Experience:
• 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 (21 CFR 820), ISO 13485, ISO 14971, and EU MDR regulations.
• Experience with orthopedic trauma implants is a plus.

• Certifications: ASQ Certified Quality Engineer (CQE) or similar certification preferred.

• Skills:
• Strong understanding of statistical process control, design of experiments, and quality management tools (e.g., Six Sigma, Lean).
• Proficiency in developing and documenting manufacturing protocols and quality records.
• Excellent communication skills (oral, written, presentation) 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, including international locations.
• 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, comprehensive benefits (medical, dental, vision), and opportunities for career growth.
• Work in a collaborative environment with a mission to deliver safe, effective, and high-quality medical devices to global markets.

Salary Range:

• TBD depending on experience and location (Reno, NV or Singapore).

How to Apply:

• Submit your resume and cover letter to careers@orthoimplantcompany.com . Please include “Quality Engineer / Regulatory Specialist – Orthopedic Devices” in the subject line.