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 requirementsConduct risk assessments and determine the need for escalation to CAPA or Health Hazard EvaluationEvaluate complaints for reportability under FDA MDR (21 CFR Part 803), EU Medical Device Regulation, and other global vigilance regulationsEnsure 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 methodologiesCollaborate cross-functionally with Operations, R&D, Regulatory Affairs, Marketing, and Customer Service teams to gather data and resolve issuesDocument 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 identifiedParticipate in internal and external audits and provide support during regulatory inspectionsSupport continuous improvement initiatives related to product quality and complaint handling processesMaintain compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable global regulationsDevelop 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 skillsExperience with root cause investigation tools and statistical analysisKnowledge of risk management principles (ISO 14971)High attention to detail and strong documentation practicesAbility to manage multiple investigations and meet regulatory timelinesAbility 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 13485Education/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%

Created: 2026-04-02