Quality Engineer - sr

1 week ago
Job ID
Quality Assurance
Position Type
Contract (Full-Time)
# of Openings


****Supervising Post Market Surveillance Engineer *****


Serve as a mentor and lead a team. Perform Post-Market supervision / management for the Spine Division complaint handling process, investigations, trending and product historical performance reports. Maintain high quality and efficiencies while also contributing to maintaining audit readiness for notified bodies


  • Supervise and mentor a team of individuals to achieve team metrics, department objectives, and provide technical expertise and guidance. 
  • Lead and participate in root cause complaint investigations and approvals, focusing on overall customer satisfaction to enhance the customer experience. 
  • Perform and approve complaint trending analysis, actively participate in Complaint Trend Review Board and lead continuous improvement processes. 
  • Provide reliability engineering expertise to support the new product development and risk management process by actively participating in, leading and approving product historical performance reports. 
  • Lead discussions with project teams, including senior leadership when necessary to improve the performance of newly developed product line(s). 
  • Ability to see the “big picture” and to communicate this effectively to a wider audience. 
  • Effectively communicate with Senior Leadership on high priority issues. 
  • Direct and manage workflow of Reliability Engineers within the scope of assigned projects; ensure understanding, application of best practices and skill development. 
  • Utilize Reliability Engineering experience to solve problems and satisfy business needs. 
  • Work closely with other QA individuals on NC assessments, CAPA investigations, Post-Market Health Risk Assessments, and Health Hazard Evaluations. 
  • Perform engineering and statistical analysis to interpret test results, determine trends, probability of failure, root cause and corrective action. 
  • Establish team goals. 
  • Assist/collaborate with manager for mid-year and year-end performance reviews for mentoring reports. 
  • Provide guidance on Individual Learning and Development Plans (IDPs) for team. 
  • Mentor other Post-Market team members in the principles of Reliability Engineering, trending, process improvements and the overall health of the Spine Post-Market Surveillance department.


  • Bachelor’s Degree in Engineering or other relevant field of study.
  • Demonstrated 5+ years of successful performance as a Reliability or Post Market Surveillance Engineer and/or greater experience in a large role leading failure investigations and/or performing failure analysis leading to root cause and corrective action.
  • Prefer 5+ years’ experience in a design and manufacturing environment.
  • Proven ability to effectively work cross-functionally with Quality, Regulatory, Product Development, Supplier Quality and Marketing.
  • Demonstrated ability to achieve work objectives both independently and as a leader/member of a work team.
  • Demonstrated problem solving and troubleshooting skills.
  • Demonstrated interpersonal and communication skills.
  • Must be results-oriented, able to multi-task, a quick learner and able to respond to the urgent needs of the team and be able to meet deadlines.
  • Applied knowledge of regulatory requirements: ISO 9001 or ISO 13485, Quality System Regulation 21 CFR 7, 803, 806 and Medical Device Directive
  • Demonstrated expertise leading failure investigations and performing Root Cause Analysis


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