Quality Engineer - sr

US-NJ-Allendale
1 week ago
Job ID
2017-27838
Category
Quality Assurance
Position Type
Contract (Full-Time)
# of Openings
1

Overview

****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

Responsibilities

  • 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.

Qualifications

  • 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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