Quality Control Technician II

Date: May 13, 2022

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 6314

 

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

Performs Incoming, In-process and final Quality Inspections and related activities.  Creates, develops and qualifies part inspection programs/routines for MicroVu and OGP Smartscope measurement system.  Supports Quality Assurance, R&D, and Manufacturing Operations in accordance with the quality system procedures.

Principal Responsibilities

•    Must be proficient in creating and developing part inspection programs/routines for the MicroVu and OGP Smartscope measurement systems.   
•    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.
•    Assist in the preparation and development of inspection instructions/procedures.
•    Generate non-conforming material reports (NCMRs) and facilitate processing NCMRs in a timely manner.
•    Administer with maintaining the equipment calibration and maintenance program and work with the calibration/maintenance service providers to ensure on-time completion of required activities.
•    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.

Education / Experience Requirements

•    High School diploma or equivalent certification required.
•    Minimum five (5) years of experience (in FDA/CE regulated medical device industry) with inspection/testing of components fabricated parts, subassemblies, product assemblies and finished devices.
•    Experience with maintaining calibration system/records is desired. 

Specialized Skills / Other Requirements

•    Proficient at creating and developing part inspection programs/routines for the MicroVu and OGP/CMM measurement systems
•    High School diploma or equivalent certification required.
•    Minimum five (5) years of experience (in FDA/CE regulated medical device industry) with inspection/testing of components fabricated parts, subassemblies, product assemblies and finished devices.
•    Proficient using microscopes, vision system (OGP Smart Scope experience preferred), and conventional hand-held inspection tools (i.e. calipers, micrometers, gage blocks, etc.), tensile testers (Instron type), torque testers, etc.
•    Proficient at reading and interpreting engineering drawings/prints/specifications,
•    Proficient with Microsoft Word, Excel, and Outlook
•    Ability to work well within and across departments to provide excellent customer service.
•    Ability to work independently, prioritizes activities, communicates well, and drives toward achieving department performance metrics.
•    Experience with maintaining calibration system/records is desired. 

 

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