Sr. Quality Engineer

Date: Jan 23, 2021

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 2838

 

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

The Senior Quality Engineer will be responsible for all aspects of Quality Engineering including the development, documentation, implementation and maintenance of quality requirements and procedures related to production, manufacturing, and operations activities.  This individual will provide Quality Engineering representation, support, guidance and participation to internal functions (primarily Manufacturing /Operations) in supporting existing products, new product introductions, and participating in various project teams.  In this position, this individual will be working in partnership with Manufacturing/Operations in the development, validation/qualification, transfer, production and maintenance of the company’s products into manufacturing.

Principal Responsibilities
  • Serve as subject matter expert in quality engineering to Manufacturing/Operations in supporting manufacturing activities/projects/initiatives (including process validations, equipment qualifications, master validation plans, product quality plans, device history records, in-process quality monitoring, manufacturing scale-up activities, and environmental monitoring).
  • Partner with Manufacturing/Operations to establish quality requirements across the manufacturing process including incoming, in-process and final product inspection and monitoring requirements.  
  • Provide quality guidance and participate in conducting risk management activities including, hazard identification, hazard analysis, failure mode effects and analysis, and risk mitigation.  
  • Support theassembly, control, approval and maintenance of various Quality records.
  • Review and analyze production/manufacturing data to determine the primary factors affecting product quality, yield, throughput, cost, and drive continuous improvement initiative with both internal and external operations as necessary.
  • Provide technical guidance to QC technicians with regards to inspections activities and drive activities to improve product quality, decrease costs, optimize inspection requirements and increase overall efficiency.
  • Support the non-conforming material process and participate in MRB meetings/discussions to address and resolve non-conformances related to products and/or processes.
  • Support CAPA activities and work in conjunction with CAPA owners in conducting investigations, root cause analysis/determination, action plans and effective checks for the effective and timely completion of CAPAs.
  • Support product complaint investigation activities and participate in returned product examinations/investigations as necessary.
  • Develop quality assurance specifications, test methods, sampling plans and related written procedures.   
  • Participate in the creation, review, approval and disposition of engineering change requests involving product or process changes.
  • Employ proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
  • Drive the use of Quality Engineering methodologies, tools, statistical techniques, etc. to assist in the resolution of day-to-day quality issues.
  • Foster the importance of quality and regulatory requirements (not just the what but also the why) and build cross functional advocates for quality within the functions supported
  • Build and maintain effective cross-functional relationships with internal departments such as Operations/Manufacturing, R&D/Engineering, Quality Control, and Regulatory Affairs. 
  • Serve as subject matter expert for areas of responsibilities during external audit activities from various government agencies and private companies & consultants (such as CA FDB, US FDA, NSAI, etc.).
  • Work in accordance with and ensure compliance with the quality system procedures related to areas of responsibility.
  • Lead department specific initiatives and projects as assigned.
  • Perform other duties as assigned by Quality Management.
Education / Experience Requirements
  • Bachelor of Science in Engineering, Technical or Life Science discipline.
  • Minimum of 8 years overall experience in Quality Engineering. 
  • Minimum of 5 years hand-on experience in ISO13485, MDD, and FDA QSR compliant Quality Systems with a medical device manufacturing company. 
  • Experience with Class II and/or III sterile devices (preferred).
  • Hand-on experience in the use and application of statistical techniques in a product development and manufacturing capacity.
  • Experience with nitinol material processing, metal fabricated components, and plastic injection molded components.
     
Specialized Skills / Other Requirements
  • ASQ Certified Quality Engineer (desirable / preferred).
  • ASQ Certified Quality Auditor (desired / preferred).
  • Strong written, oral, and interpersonal skills.
  • Strong analytical skills, problem solving techniques and statistical application experience.
  • Knowledge in the areas of Manufacturing Process Validation, high-volume manufacturing practices/principles, 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