Post Market Quality Engineer
Florida, Fort Lauderdale
Our client, a Global Medical Device Manufacture has an immediate opening for a Post MarketQuality Engineer for a 12 Month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
As an Engineer Post Market you will provide quality engineering support in post market surveillance, with a focus on complaint handling, complaint investigations and complaint trend analysis. You will advocate and lead the execution of initiatives & projects to enhance quality performance as part of Continuous Improvement. Ensure compliance to regulation and standards.
You will work closely with complaint investigators to investigate and resolve product complaints.
You will review and approve complaint investigations.
You will participate in the development and improvement of the design of existing and new products.
You will maintain KPIs for post market quality, perform analysis and interpret trends, take action as necessary.
You will develop understanding of risk management practices and concepts, ability to become proficiency in risk management.
You will develop proficiency in statistical methods and application.
You will participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audits preparation building confidence and proficiency in interactions with same.
You will participate in design related CAPAs
What you need
Bachelor s degree in engineering or related discipline
3-5 years of experience in engineering or post market within a regulated industry
Familiarity with ISO 13485, GDP, GMP concept desirable.
Knowledge of engineering and quality concepts
Knowledge of Risk Based and statistical concepts desirable.
Problem solving and analytical skills.
Strong communications, respect and trust.