The Orthopaedic Implant Company · 6 hours ago
Quality Engineer / Regulatory Specialist - Reno, NV and/or Singapore
Reno, NV
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expThe Orthopaedic Implant Company is seeking a talented Quality Engineer / Regulatory Specialist with experience in orthopedic medical devices to ensure the highest standards of quality and compliance for their innovative products. This role involves establishing and maintaining robust quality management systems and regulatory strategies, collaborating with cross-functional teams, and driving continuous improvement in product quality and safety.
Health CareHospitalMedicalMedical Device
Responsibilities
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
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
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
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)
Qualification
Required
Bachelor's or Master's degree in engineering (Mechanical, Biomedical, or related), 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 (21 CFR 820), ISO 13485, ISO 14971, and EU MDR regulations
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
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
Preferred
Experience with orthopedic trauma implants is a plus
Certifications: ASQ Certified Quality Engineer (CQE) or similar certification preferred
Benefits
Medical
Dental
Vision
Company
The Orthopaedic Implant Company
The Orthopaedic Implant Company, a Zeda Health Company, is more than an implant company.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2024-02-13Acquired
Leadership Team
Stephen Lichtenthal
Vice President of Sales and Business Development
Recent News
Company data provided by crunchbase