Date: Mar 13, 2019
Location:Pleasanton, CA, US
Expected Travel: Up to 25%
Requisition ID: 627
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.
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 initial 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. The UroLift System lifts or holds the enlarged prostate tissue so it no longer blocks the urethra. Over 100,000 global patients have been treated with UroLift. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
The Supplier Development Engineer is responsible for all aspects of Supplier Quality Engineering and NeoTract's Supplier Management Program, including supplier evaluations, supplier selection/approvals, supplier maintenance, and supplier improvement/development activities. As an integral member of the Quality team, this position partners with Operations and R&D in selecting and managing the supply base and driving supplier improvement activities/initiatives to support NeoTract's manufacturing, product development, and business objectives. This position requires knowledge of applicable regulations and standards, including FDA, QSR, ISO, MDD, and IVDD; experience conducting external Quality System assessments; and the ability to perform at high-levels in a fast-paced, dynamic environment.
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 containing supplier evaluation, approval, maintenance, and correspondence in accordance with applicable procedures.
Monitor, track, and report supplier performance, and work with suppliers on quality issues.
Oversee and manage supplier performance for quality and customer service/responsiveness, provide feedback to suppliers 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 initiatives with suppliers as necessary
Follow-up on corrective and preventive actions related to supplier audit findings, nonconforming product/material, and 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.).
Partner with Quality Control, Operations, and Engineering to identify opportunities for continuous improvement of supplier quality, resolution of non-conforming material issues, and reduced and alternate inspection opportunities (dock-to-stock, skip lot inspections, etc.).
Build and maintain effective cross-functional relationships with suppliers and internal departments, including Operations/Manufacturing, R&D/Engineering, Quality Control, and Regulatory Affairs.
Support department specific initiatives and projects as assigned.
Perform other duties as requested.
Contribute to the Company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!
Education / Experience Requirements
Bachelor of Science in Engineering or Life Science discipline; or equivalent experience.
At least 3 years of overall experience in Quality Assurance, medical device manufacturing, or pharmaceutical industries preferred.
At least 3 years of experience as a Supplier Quality Engineer preferred.
Experience with Class III sterile devices preferred.
Excellent written, oral, and interpersonal communication skills.
Experience as a trained Lead Auditor in conducting external Quality System assessments (preferably as a Certified Lead Auditor).
Experience with nitinol material processing, components, and products is desired.
Specialized Skills / Other Requirements
Demonstrated knowledge of applicable regulations and standards such as FDA, QSR, ISO, MDD, & IVDD.
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.
Domestic and International travel to suppliers and contract manufacturers as needed (10-20%).
Active driver's license issued from residing state, and clean driving record.
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, Rsch, UroLift and Weck trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.