Sr. Quality Control Technician

Date: Jan 6, 2022

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 5212

 

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.

 

US COVID-19 Vaccination Requirements

Teleflex is focused on the health and safety of our employees, their families, and our customers. Teleflex will comply with US government regulations regarding COVID-19 vaccination requirements for US workers. To ensure we are prepared for all applicable vaccination requirements, Teleflex is currently collecting vaccination status and accommodation requests from our US based employees.

Employees and new hires in sales or field-based roles that require vendor credentials to access medical facilities as an essential function of the job, may be required to obtain the COVID-19 vaccination based on customers/site requirement. This requirement is independent of Teleflex policy or any applicable US governmental regulations.

 

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 Sr. Quality Control Technician performs incoming, in-process, finished device inspections, and other related activities.  As an integral member of the Quality Assurance/Regulatory Assurance team, this position supports cross-functional teams including Quality Assurance, R&D, and Manufacturing/Operations in accordance with applicable quality system procedures.  This position requires proficiency using a MicroVu measurement system, experience testing and inspecting material components, and the ability to work independently in a fast-paced, dynamic environment.

Principal Responsibilities

•    Program and use a MicroVu system for manual and automated part inspection.
•    Create, develop, and qualify part inspection programs/routines for a Micro-Vu measurement system (using Excel and Vertex).
•    Train other inspectors and technician on using an automated Micro-Vu measurement system to inspect activities per instructions and procedures.
•    Perform first article inspection and special inspection requests as needed.  
•    Perform incoming/receiving inspections in accordance with established SOP and specifications.
•    Perform in-process and final inspection of in-house manufactured product per established SOP requirements, instructions in traveler and/or documents referenced on the traveler.
•    Record and document inspection results/findings on applicable data sheets/forms.
•    Review inspection records and device history records for completion and accuracy.
•    Assist in the preparation and development of inspection instructions/procedures.
•    Generate non-conforming material reports (NCMRs) and facilitate processing NCMRs in a timely manner.
•    Perform testing/inspection activities per approved protocol instruction (such as tensile test, accelerated aging test, verification/validation testing, etc.).
•    Ensure completion of inspections in a timely manner and track/report activities and metrics.
•    Track, compile, analyze and report system performance data and prepare applicable reports as they pertain to Quality Control activities.
•    Participate in internal audits as requested.
•    Organize, maintain and secure inspection records to provide for good documentation practices and efficient retrieval.
•    Perform department clerical tasks as assigned to support department activities.
•    Work in accordance with and ensure compliance with the quality system procedures related to work activities
•    Perform other duties as assigned by Quality Management.
•    Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Education / Experience Requirements

•    High School diploma or equivalent certification; or equivalent experience.
•    At least 5 years of experience inspecting and testing components and fabricated parts, sub-assemblies, product assemblies, and finished devices; preferably in the FDA/CE regulated medical device industry.
•    Experience conducting device history record reviews (lot/batch record review) and component/product release activities.
 

Specialized Skills / Other Requirements

•    Proficiency using microscopes, vision system (Micro-Vu experience preferred), and conventional handheld inspection tools (e.g., calipers, micrometers, gage blocks, etc.), tensile testers (Instron type), torque testers, and other related tools.
•    Proficiency in reading and interpreting engineering drawings, prints, and specifications.
•    Proficiency in Microsoft Word, Excel, and Outlook.
•    Ability to provide excellent customer service within and across departments.
•    Ability to work independently, prioritize activities, and support the achievement of department performance goals, objectives, and metrics.

 

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