Sr. Supplier Quality Engineer

Date: Oct 27, 2020

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 3010

 

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

Responsible for all aspect of Supplier Quality Engineering and NeoTract’s Supplier Management Program, including supplier evaluations, supplier selection/approvals, supplier maintenance, and supplier improvement/development activities.  In this position, this person will be working in conjunction with the Operations and R&D functions in selecting and managing the supply base and driving supplier improvement activities/initiatives to support NeoTract’s manufacturing, product development and business objectives.  The Sr. Supplier Quality Engineer serves as the primary quality and technical interface between NeoTract and the supply base.

Principal Responsibilities

•    Serve as the primary quality and technical interface between NeoTract and the supply chain (subcontractors, suppliers, and service providers).
•    Conduct supplier evaluations, selection, maintenance, qualification/validation and record keeping activities in accordance with established requirements and procedures. 
•    Conduct supplier audits and issue reports detailing audit findings and observations. 
•    Maintain and control supplier files contain supplier evaluation, approval, maintenance and correspondence in accordance with applicable procedures.
•    Monitor, track and report on supplier performance and work with suppliers on quality issues. 
•    Oversee and manage supplier performance with respect to product quality and customer service/responsiveness, provide feedback to supplier as necessary and drive supplier performance levels to support business needs/objectives.
•    Support supplier development and continuous improvement activities targeted at achieving department objectives and meeting business needs/objectives.
•    Review and analyze production/manufacturing data to determine the primary factors affecting product quality, yield and cost and drive continuous improvement initiative with supplier as necessary
•    Follows up on corrective and preventive actions related to supplier audit findings, nonconforming product/material and/or overall supplier performance to ensure effective resolutions and timely closure. 
•    Assist in the development, approval, and maintenance of material specifications, supplier requirements/instructions, quality assurance procedures, supplier agreements, and supplier documentation (e.g. Quality Plans, Work Instructions, Protocols, Reports, FMEAs, etc.). 
•    Work with Quality Control, Operations and Engineering personnel to identify opportunities for continuous improvement with respect to supplier quality, resolution of non-conforming material issues, and reduced and/or alternate inspection opportunities (dock-to-stock, skip lot inspections, etc.).
•    Build and maintain effective cross-functional relationships with suppliers and internal departments such as Operations/Manufacturing, R&D/Engineering, Quality Control and Regulatory Affairs. 
•    Supporting department specific initiatives and projects as assigned.
•    Domestic and International travel to suppliers and contract manufacturers as needed (40%)
AUTHORITIES:
•    The guidance, recommendations, feedback, actions and decisions made by the Supplier Quality Engineer are critical in ensuring acceptable supplier performance, compliance with internal and external requirements/regulations, and the ability to successfully meet business needs and objectives.  
•    The successful management and development of suppliers has a direct impact on product costs and quality aspects of the business.  Additionally, the impact of such guidance, decisions, and recommendations can have a direct effect on the company’s ability to design/develop new products and manufacture/produce existing products.
•    The Supplier Quality Engineer position has signature authority for the Quality Department as it relates to supplier management and oversight activities. 

Education / Experience Requirements

•    Bachelor of Science in Engineering or Life Science discipline.
•    8 years overall experience in Quality Assurance; minimum 5 years experience in medical device manufacturing or pharmaceutical industries, minimum 3 years experience as a Supplier Quality Engineer. 
•    Experience with Class III sterile devices preferred.
•    Trained and experienced Lead Auditors in conducting external Quality System assessments (preferably a Certified Lead Auditor).
•    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.
•    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.

© 2020 Teleflex Incorporated. All rights reserved.


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland