Manager, Design Quality Assurance

Date: Sep 9, 2021

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4471

 

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 Manager, Design Quality Assurance is responsible for all aspects of Design Quality Assurance Engineering and oversight/management of Quality personnel supporting design control and product development activities. As an integral part of the quality organization team, this position develops, documents, implements, and maintains quality system requirements and procedures related to design, development, and pre-production manufacturing activities.  In addition, this position participates and provide quality engineering oversight, management, support, guidance for Neotract functions departments (such as, R&D, Manufacturing/Operations, and Regulatory). This position is responsible for managing a diverse team of quality engineers and technicians that are actively involved in development, verification, validation, manufacturing, and approvals for new products. This position requires adaptability and flexibility in a dynamic, fast-paced environment. As people’s manager, s/he leads, supports, mentors and coach’s quality engineers and technicians team members as they execute their daily activities.

Principal Responsibilities

•    Supervise, mentor and coach, support, train and develop a highly effective Quality Engineers and Technicians 
•    Manage the activities and performance of Design Quality Assurance Engineers and Technicians supporting design control and all associated product development activities.
•    Oversee validation of product sterilization processes (including dose map studies) per industry standards.
•    Oversee product biocompatibility testing of new products per industry standards (ISO10993).
•    Establish Quality Engineering requirements and inspection/test methodologies for new products across the manufacturing process, including incoming, in-process and final product inspection and monitoring requirements (in conjunction with Manufacturing/Operations)
•    Provide Quality Engineering oversight and guidance to ensure product development deliverables meet internal and external regulatory requirements, including customer requirements, design specifications, design verifications, design validations, risk management, quality plans and associated deliverables.
•    Provide Quality Engineering oversight and guidance in conducting risk management activities including, hazard identification, hazard analysis, failure mode effects, and analysis, and risk mitigation.
•    Oversee the assembly, control, and maintenance of product Design History Files, Device History Records, Risk Management Files, Usability Files, and Technical Files/Design Dossiers.
•    Evaluate and assess 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 to the point of manufacturing transfer.
•    Provide technical assistance/guidance and training to the QC function related to inspection methodologies, techniques, processes, and requirements for new products/parts/components.
•    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.
•    Oversee the development of quality assurance specifications, inspection & test methods, sampling plans and related written procedures with the objective of driving improve product quality, decrease costs, optimize inspection requirements and increase overall efficiency.
•    Participate in the creation, review, approval, and disposition of engineer change requests involving product or process changes.
•    Develop, apply, and promote proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
•    Develop, apply, and promote the use of Quality Engineering methodologies, tools, statistical techniques, etc. to assist in the resolution of quality issues during product development.
•    Promote and maintain effective cross-functional relationships with internal departments such as Operations/Manufacturing, R&D/Engineering, Quality Control, Sales/Marketing, and Regulatory Affairs.
 

Education / Experience Requirements

•    Bachelor’s degree and 10+ years of hand-on experience in IS013485, MDR, and FDA QSR compliant Quality Systems in a medical device industry 
•    Minimum of 5 years management experience preferred
•    Experience with Class II and/or Ill sterile devices (preferred).
•    Hand-on experience in the use and application of statistical techniques in a product development and manufacturing capacity.
•    Experience in sterilization validations (radiation) and biocompatibility testing of products

Specialized Skills / Other Requirements

•    ASQ Certified Quality Engineer or ASQ Certified Quality Manger (desired/ preferred)
•    Demonstrated knowledge of applicable regulations and standards such as FDA, QSR, ISO, MDD, & IVDD.
•    Strong written, oral, and interpersonal communication skills.
•    Strong analytical skills, problem-solving techniques and statistical application experience.
•    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.


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