Quality Engineer I

HighRidge Medical LLC•Westminster, CO

39d

About The Position

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.

Requirements

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
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.

Nice To Haves

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)

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.