Quality Engineer

Job Summary

We are seeking a talented Quality Engineer / Regulatory Specialist with experience in orthopedic medical devices to ensure the highest standards of quality and compliance are met for our innovative products. 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. The candidate will work closely with cross-functional teams, including R&D, engineering, manufacturing, and regulatory affairs, to ensure compliance with FDA, ISO 13485, EU MDR, and other global regulations, while driving continuous improvement in product quality and safety for orthopedic devices such as implants and associated instrument systems.

Key Responsibilities 1. 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.

2. 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.

3. 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.

4. 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 1. Education

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

2. 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.

3. Certifications

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

4. 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.

5. 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.

How to Apply

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

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