Sr. Design Quality Assurance Engineer

Date: Nov 23, 2021

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 4019

 

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

As an integral member of the Quality Team, the Senior Design Quality Assurance Engineer partners with internal customers for product development and pre-production manufacturing activities.  This person will provide Quality Engineering representation and guidance to R&D in supporting projects for new product introductions and various projects.  In this position, this person will partner with R&D, Manufacturing/Operations, and Regulatory in the development, verification, validation, manufacturing, and approvals for new products.

Principal Responsibilities

  • Serve as Quality Representative to R&D in supporting design control and all associated product development activities (including customer requirements, design specifications, design verifications, design validations, risk management, technical documentation, and quality plans).
  • Partner with R&D to develop a structured software development process for software-based products
  • Manage the validation of product sterilization processes (including dose map studies) per industry standards.
  • Manage biocompatibility testing of new products per industry standards (ISO 10993).
  • Partner with Mfg/Operations to establish quality requirements across the manufacturing process including incoming, in-process and final product inspection and monitoring requirements.  
  • Partner with internal customers to perform  risk management activities including, hazard identification, hazard analysis, failure mode effects and analysis, and risk mitigation consistent with ISO 14971.
  • Partner with R&D and Operations for control and maintenance of product Design History Files, Device History Records, Risk Management Files, Usability Files and Technical Documentation.
  • Review and analyze pre-production/manufacturing data to determine the primary factors affecting product quality (including product complaints), yield, throughput, cost, and drive continuous improvement initiative with both internal and external operations as necessary.
  • Provide technical assistance/guidance to QC technicians in regard to inspection activities and drive activities to improve product quality, decrease costs, optimize inspection requirements and increase overall efficiency.
  • Assist/support the non-conforming material process and participate in MRB meetings/discussions to address and resolve non-conformances related to products and/or processes.
  • Assist/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.
  • Partner with the Product Complaints group for investigations of returned product which include examinations/investigations as necessary to arrive at root cause and implement corrective and/or preventive actions.
  • Develop quality assurance specifications, test methods, sampling plans and related written procedures.   
  • Create, review, and approve Engineering Change Orders for product or process changes.
  • Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
  • Apply the use of Quality Engineering methodologies, tools, statistical techniques, etc. to assist in the resolution of day-to-day quality issues.
  • Build and maintain effective cross-functional partnerships with internal departments such as Operations/Manufacturing, R&D/Engineering, Quality Control, Sales/Marketing, and Regulatory Affairs. 
  • Support external audit activities from various government agencies and private companies & consultants (such as CA FDB, US FDA, NSAI, etc.) as necessary.
  • Lead projects/initiatives to improve quality system and procedures to ensure compliance to regulations..
  • Take on a lead role in 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 or equivalent experience required
  • Minimum of 8 years hands-on experience preferred in a Quality/Engineering role in an ISO 13485, MDD, and FDA QSR compliant medical device manufacturing company.
  • Experience with Class II and/or III sterile devices (preferred).
  • Experience with metal fabricated components and/or plastic injection molded components.
  • Experience in sterilization validations (radiation) and biocompatibility testing of products
  • Experience with IEC 60601 and/or IEC 62304 requirements 
     

Specialized Skills / Other Requirements

  • ASQ Certified Quality Engineer (desired / preferred).
  • ASQ Certified Quality Auditor (desired / preferred).
  • Strong written, oral, and interpersonal skills.
  • Strong analytical skills, problem solving techniques and statistical application experience.
  • Hand-on experience in the use and application of statistical techniques in a product development and manufacturing capacity.
  • Extensive knowledge in the areas of Design Controls, Design Validation & Verification, Risk Management, Process Validation, 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.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland