Manager, Supplier Quality Engineering

Date: Jun 23, 2022

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 5956

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

 

Interventional Urology – NeoTract is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. As part of the Teleflex Interventional Urology business unit, NeoTract’s focus is on improving the standard of care for patients with benign prostatic hyperplasia (BPH) using the UroLift® System, a minimally invasive, permanent implant system that treats symptoms while preserving sexual function*1,2. The UroLift System is clinically proven to treat lower urinary tract symptoms due to BPH in men over the age of 45. The UroLift System lifts or holds the enlarged prostate tissue out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue. More than 175,000 men have been treated with the UroLift System in select markets worldwide.** Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives. 

 * No instances of new, sustained erectile or ejaculatory dysfunction in the FDA pivotal study.

** Management estimate based on product sales and average units per procedure

  1. Roehrborn, J Urology 2013 LIFT Study
  2. McVary, J Sex Med 2014

Indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older. As with any medical procedure, individual results may vary. Most common side effects are temporary and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate and/or the inability to control the urge.1 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Speak with your doctor to determine if you may be a candidate.

Position Summary

#LI-DNI

Overall responsible for developing, implementing, maintaining, and overseeing all aspects of NeoTract’s Supplier Quality Engineering program and ensuring the necessary systems, procedure, and processes are established to support both current and future business needs. Oversee all aspects of supplier management including supplier evaluations, supplier selection/approvals, supplier maintenance, supplier performance monitoring, and supplier improvement/development activities. 

In this position, this person will work in conjunction with the Operations and R&D functions in selecting, managing and maintaining the supply base, driving acceptable supplier performance, pursuing supplier improvement activities/initiatives, and implementing and overseeing strategic supplier management programs such as Supplier Certification, Alternative Inspection Methods, Supplier Performance and Recognition, and Continuous Improvement initiatives.

The Supplier Quality Engineer Manager will ensure the implementation of company-wide quality systems policies and procedure as they relate to Supplier Management and Supplier Quality and will manage associated staff to support NeoTract’s Supplier Management Program.
 

Principal Responsibilities

•    Implementing and maintaining the effectiveness of the Quality System as it relates to Supplier Quality Management.
•    Develop, prioritize, provide direction and monitor progress toward Supplier Quality Engineering department goals, objectives, and initiatives.
•    Manage Supplier Quality Engineering staff to ensure ample coverage and support for Operations and R&D projects and product approval and release activities as it relates to external suppliers.  
•    Ensure the NeoTract Approved Supplier List and corresponding supplier files are maintained and accurate.
•    Drive and support continuous improvement plans and activities at suppliers
•    Ensure appropriate validation and qualification of applicable supplier processes, methods and equipment at suppliers.
•    Ensure the on-time completion of all required supplier maintenance activities such as quality audits/assessments, process audits, business reviews/assessments, regulatory assessments, and quality contract/agreements and performance monitoring/feedback with suppliers.
•    Serve as Subject Matter Expert during internal and external audits as it relates to NeoTract’s Supplier Quality Management program.
•    Ensure the hiring and development of qualified Supplier Quality Engineering staff, provide growth path/opportunities and professional development and guidance as appropriate.
•    Establish and maintain successful cross-functional relations with internal departments/functions such as Operations/Manufacturing, R&D/Engineering, Quality Control and Regulatory Affairs. 
•    Manage department expense in-line with approved department budgets.
•    Fulfill day-to-day Supplier Quality Engineer activities as describe in the Supplier Quality Engineer job description, as necessary.  
•    Supporting department specific initiatives and projects as assigned.
•    Domestic and International travel to suppliers and contract manufacturers as needed (15-30%)

Education / Experience Requirements

•    Bachelor of Science in Engineering or Life Science discipline.
•    10 years overall experience in Quality Engineering/Assurance with a minimum of 5 years in Supplier Quality Engineering; minimum 5 years experience in medical device manufacturing or pharmaceutical industries. 
•    Experience with Class III sterile devices preferred.
•    Experience with nitinol material processing, components, and/or products is desired.

Specialized Skills / Other Requirements

•    Demonstrated knowledge of applicable regulations and standards such as FDA, QSR, ISO, MDD, & IVDD.
•    Strong written, oral, and interpersonal skills.
•    Trained and experienced Lead Auditors in conducting external Quality System assessments (preferably a Certified Lead Auditor).
•    Strong analytical skills, problem solving techniques and statistical application experience.
•    Knowledge in the areas of Supplier Management, Design Controls, Process Validation, manufacturing practices, and statistical techniques.

 

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland