Job Description : Quality Engineer
The Post-Market Quality Engineer works cross-functionally with quality, operations, sales, field service, and sustaining engineering to support products that have been released to the field.
This position plays a critical role for the business by investigating customer feedback and performing product performance monitoring and trending.
In this role you will conduct product performance investigations that will lead to design, manufacturing and use improvements.
This position will ensure product performance trends are distributed on a recurring basis for leadership review as part of the management review process.
Participate in the complaint handling process by leading complaint investigations
Apply engineering judgement and product knowledge to properly assess returned devices
Perform complaint investigations, including, as appropriate, decontaminate and analyze returned devices, determine root cause, identify non-
conformances, initiate health risk assessments, and generate reports and trends
Proactively work with other departments (R&D, Manufacturing, Quality, Design Assurance, Marketing, Regulatory, Field Service) to review returned devices and root causes, as necessary, to support investigations
Meet goals and metrics to timely and accurately complete investigations of complaints in support of medical device regulatory reporting
Identify high-level complaints or incidents that may have a significant impact on the business.
Proactively follow steps to judge escalation of high priority and / or complex product complaint investigations and corrective actions
Perform or arrange for testing on complaint products, as necessary
Support investigation into complaints of distributed devices and supplier-manufactured products / components, working with external contacts and Supplier Quality to facilitate their investigations
Identify and implement changes to relevant QA monitoring programs to improve effectiveness and efficiency
Perform data analysis to generate product performance trending reports for senior leadership review and decision-making
Produce and maintain documentation in accordance with applicable regulations
Participate in external audits and inspections as a subject matter expert on complaint investigations and returned product analysis
Maintain quality system process for complaint investigations
Ensure predicate product performance is understood and provided to new product development teams.
Bachelor's Degree in technical or life sciences, or engineering
Complaint handling experience in a regulated environment
2-5 years Quality Engineer experience
Proficiency in MS Word, Excel, Access. Must read, write and understand English
Self-motivated and energetic
Strong interpersonal skills and ability to work / influence cross functional teams
Problem solving ability
Ability to prioritize effectively
Ability to multi-task in a fast-paced environment
Oral and written presentation skills
Experience with electromechanical equipment or injection molding products is a plus
Working knowledge of FDA GMP / GLP, Medical Device Directive, and ISO
ASQ Quality Engineer and / or Six Sigma Green Belt certification a plus