Manager, Quality Control

Date: Dec 29, 2021

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 5138

 

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 Manager, Quality Control is responsible for all aspects of Quality Control and oversight/management of Quality Inspectors personnel supporting Quality Control and Inspection activities. As an integral part of the quality organization team, this position partners with cross-functional teams, including Quality Assurance, R&D, and Manufacturing / Operations, to manage quality control processes in accordance with applicable quality system procedures.  This position is responsible for managing a diverse team of quality inspectors and technicians that are actively involved in Quality Control, Incoming and Manufacturing Process Inspection activities. This position requires proficiency using a MicroVu measurement system, experience managing testing and inspecting activities, and the ability to work independently in a dynamic, fast-paced environment. As people’s manager, s/he leads, supports, mentors and coach’s quality inspectors and technicians as they execute their daily activities.

Principal Responsibilities

•    Manage and motivate a high-performing Quality Technicians and Inspectors by communicating job expectations, developing action plans, monitoring, appraising work performance, and providing guidance on challenging situations.
•    Provide technical assistance/guidance and training to the Quality Technicians and Inspectors related to inspection methodologies, techniques, processes, and requirements for new products/parts/components.
•    Establish Quality Control and Inspection requirements and inspection/test methodologies for products across the manufacturing process, including incoming, in-process and final product inspection and monitoring requirements (in conjunction with Manufacturing/Operations)
•    Supervise, recruit, mentor and coach, support, train and develop highly performing and effective Quality Technicians and Quality Inspectors. 
•    Manage part inspection activities, including inspections using an automated Micro-Vu measurement system, incoming/receiving inspections, and final inspection of in-house manufactured products per established SOP requirements.
•    Manage inspections as needed to meet department goals and metrics.
•    Manage document inspection results and findings in applicable data sheets and forms.
•    Oversee the preparation and development of inspection instructions and procedures.
•    Assist/support the non-conforming material process (NCMR) and participate in MRB meetings/discussions to address and resolve non-conformances related to products/parts/components/ or processes.
•    Lead the generation and processing of non-conforming material reports (NCMRs) in a timely manner.
•    Manage the creation, review, approval, and disposition of engineer change requests involving incoming/receiving inspections, and final inspection of in-house manufactured products or process changes.
•    Manage testing/inspection activities per approved protocol instructions, including but not limited to tensile testing, accelerated aging testing, verification/validation testing, etc.
•    Manage completion of inspections in a timely manner and track/report activities and metrics.
•    Partner with Senior Management to develop and manage the Quality Control budget.
•    Participate in internal audits as requested.
•    Supervise the assembly, control, and maintenance of inspection and Device History Records (DHR)
•    Manage inspection records to ensure proper documentation practices and efficient retrieval.
•    Work in accordance with the quality system procedures related to work activities. Lead department specific initiatives and projects and 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

•    Bachelor’s degree or equivalent certification and 7+ years of hand-on experience in IS013485, MDR, and FDA QSR compliant Quality Systems in a medical device industry 
•    Associate degree or equivalent certification or 10+ years of hand-on experience in IS013485, MDR, and FDA QSR compliant Quality Systems in a medical device industry 
•    Minimum of 5 years of hand-on experience in supervising or managing the team of Quality Inspectors and Technicians in the inspection and testing of components and fabricated parts, sub-assemblies, product assemblies, and finished devices
•    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.
•    Proficient in Microsoft Word, Excel, and Outlook.
•    Ability to make critical decisions, prioritize activities, and support the achievement of department performance goals, objectives, and metrics.
•    Excellent verbal and written communication skills.
 

 

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