DIRECTOR OF QUALITY ENGINEERING-MED DEVICE

Location: HOMESTEAD, PA
Date Posted: 07-12-2018
We are pleased to present the following job opportunity with our client!  Take a look and if you meet the requirements please submit your resume and we'll be in touch if you're a good fit!
 
At the heart of this fast-growing company, the Director of Quality Engineering must be a creative, dynamic leader and an active manager who excels at leading complex, essential and game-changing projects. This is an opportunity to lead a small team in Pittsburg of highly passionate and dedicated engineers in an environment similar to a start-up but with the stability of a well-funded and branded global medical device company.  You will be part of the leadership team, leading the development, implementation, and maintenance of Quality Engineering functions within the franchise.
 
Reporting to the Vice President of Quality, you will be responsible for all aspects related to quality control, internal/external audit operations, products non-conformity execution, compliance and measurement within the plant. You will also support the QMS in the development and improvement of quality systems and procedures that would improve the effectiveness of the quality assurance program. As a part of this, you will monitor and ensure that all quality inspection processes, programs, and systems comply with procedures and regulatory requirements (e.g., FDS, ISO13485, European Medical Device Directive 93/42/EEC, applicable US 21CFR requirements, Japan PAL and ordinance #169,  Canada Medical Device Regulation, Australia TGA regulation and others as appropriate).
 
To be successful in this role, you will need to understand how to manage immature medical device designs and processes through the new product development life cycle and scale them globally.  You will need to have a high degree of technical and business acumen with a solid understanding of global GMP regulations. You will have earned your Bachelors of Engineering or Science and should have at least ten years’ experience in medical device quality or regulatory management. 
 
Key Responsibilities:
  • Set the Quality engineering annual budget and identify resource needs to maintain the processes; Set the Quality engineering department's objectives and ensure alignment to the organization's goals and strategic plan
  • Support and collaborate with Customer QA ensuring the best in class Quality Engineering support
  • Ensure the compliance of the design control process to the design control requirements and quality system procedures, within the NPD and sustaining projects
  • Lead the CAPA process, ensuring CAPA's are initiated whenever it makes sense according to quality system procedures; ensure proper leadership within the problem review board, root cause investigation analysis board and the change board over the product development lifecycle
  • Coordinate the Quality Review Board when the risk posed by nonconforming products indicate for FSCA initiation
  • Define and implement quality initiatives to enhance systems efficiencies, productivity, and quality. Act as a task leader in system change definition and implementation
  • Support external audit group in identifying the level of plant exposure/risks area and which remediation might be required and in defining if an independent plant assessment is required to determine the level of site readiness
  • Interface with regulatory authorities or notified bodies during site's inspections
  • Ensure plant preparation for incoming inspection and inspection management in compliance with regulations and internal quality guidelines
  • Define and administer quality and quantity metrics programs that measure inspection efficiency and effectiveness.
  • Support the Internal/External Audits Manager in defining response to FDA and lead the process to respond other regulatory authorities or notified bodies
  • Support cost savings programs and implements changes that will reduce costs without adversely impacting quality
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
"Bringing Talent to the Marketplace"

KP Recruiting Group is a well established and very respected recruiting firm.  We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients.  We are very experienced in many industries and have a wide range of clients.  We will serve as your advocate during your career search!  Let us do the work for you!  There is never a fee for our services!



 
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