Quality Engineer I en undefined

Job Summary:

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:

• Investigates customer complaints, completes risk assessments, and determines the need for escalation to CAPA or Health Hazard Evaluation.
• Ensures 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.
• Performs trending and data analysis on complaint data to identify issues for escalation
• Uses applicable quality tools to complete root cause analysis such as 5 whys, Fishbone diagram, pareto charts, Fault Tree Analysis, etc.
• Develops and implements corrective/preventative action plans.   
• Works closely with other departments to ensure thorough and accurate investigations, complaint trending, and visibility to Health Risk Assessments and Corrective & Preventive Actions (CAPA) when appropriate.
• Provides support during inspections by regulatory bodies.
• Formulates procedures, specifications, and standards for Highridge Medical QMS.
• Evaluates processes and implements continuous improvements to QMS processes 

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

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.). 
• 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 21CFR820 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). 
• 3-5 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%