Quality Engineer I

Job Summary: 

Highridge Medical creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents to demonstrate Confidence in your work and restore Confidence for our patients. Confidence that moves.

The Post Market Surveillance Quality Engineer ensures post market surveillance activities including, complaint processing, health authority reporting and post-production performance reports are completed in a timely and compliant manner.  Coordinates quality planning, identifies and solves product and process problems and supports various operational groups.

Principal Duties and Responsibilities:

• Lead end-to-end investigation of product complaints, ensuring timely closure in accordance with internal procedures and regulatory requirements
• Conduct risk assessments and determine the need for escalation to CAPA or Health Hazard Evaluation
• Evaluate complaints for reportability under FDA MDR (21 CFR Part 803), EU Medical Device Regulation, and other global vigilance regulations
• Ensure Health Authority Reporting is completed in compliance with applicable domestic and international regulations, standards, and guidance documents such as Federal Drug Administration 21 CFR Part 820, ISO 13485, EU Medical Device Regulation, Vigilance, MEDDEV, etc., and post-production performance.
• Conduct root cause analysis using tools such as 5-Why, Fishbone (Ishikawa), Fault Tree Analysis, or similar methodologies
• Collaborate cross-functionally with Operations, R&D, Regulatory Affairs, Marketing, and Customer Service teams to gather data and resolve issues
• Document investigation findings clearly and accurately within the electronic Quality Management System (eQMS)
• Identify trends in complaint data and support risk analysis updates (FMEA, Risk Management Files)
• Initiate and support CAPA activities where systemic issues are identified
• Participate in internal and external audits and provide support during regulatory inspections
• Support continuous improvement initiatives related to product quality and complaint handling processes
• Maintain compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable global regulations
• Develop and implement corrective/preventative action plans.   

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Expected Areas of Competence (i.e. knowledge, skills, and abilities) 

• Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.). 
• Strong analytical and problem-solving skills
• Experience with root cause investigation tools and statistical analysis
• Knowledge of risk management principles (ISO 14971)
• High attention to detail and strong documentation practices
• Ability to manage multiple investigations and meet regulatory timelines
• Ability to deliver, meet deadlines and be results oriented. 
• Strong technical writing and presentation skills.
• Experience with electronic QMS software and the Microsoft Office Suite 
• Good working knowledge of applicable, standards and regulations such as FDA 21 CFR820 and ISO 13485

Education/Experience Requirements:

• B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE). 
• 1-3 years of work experience. 
• Certified Quality Engineer (CQE) and medical device, particularly Orthopedic industry, experience preferred 
• Combination of education and experience may be considered (in evaluating experience relative to requirements) 

Travel Requirements

 Up to 10%