Post Market Surveillance/Complaint Analyst II

Date: Oct 14, 2021

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 4695


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


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 Complaint Analyst is responsible for product complaint documentation, investigations, and identification of potential adverse events and incidents that require further review or escalation.  As an integral member of the Quality team, this position develops customer communications and interfacing for all stakeholders, including physicians, nurses, hospital personnel, Urology Consultants, and others regarding product complaints.  This position requires knowledge of FDA quality system regulations, strong complaint analytical skills, and the ability to perform at high levels in a fast-paced, dynamic environment.

Principal Responsibilities

•    Facilitate complaint investigations while ensuring completeness and consistency of complaint files/records, and participate in generating reports for complaint data, metrics and trends.
•    Perform preliminary classification of complaints and escalate events that require additional review for reporting (e.g., Medical Device Reporting, Medical Device Vigilance, international event reporting, etc.).
•    Evaluate documentation for completeness and consistency and assign additional actions as necessary to assess and investigate complaints.
•    Follow up with customers if additional information is required. 
•    Escalate complaints when encountering new failure modes, and partner with OEM, Engineering, Field Personnel, and Quality Assurance to investigate.
•    Collaborate with clinical and medical staff on hazard evaluation, potential patient risk, and safety hazard investigations.
•    Monitor and report on trends related to complaints and escalate issues to management.
•    Adequately address all complaints requiring customer responses.
•    Review and process complaints with sufficient information and complete all relevant tasks before closing.
•    Initiate corrective action per company CAPA procedure to prevent product non-conformance.
•    Participate in Quality Audit Teams and Management Reviews.
•    Assist in updating Quality procedures as required through the ECO process.
•    Stay current with technology, practices, and general engineering knowledge relevant to the field through seminars, literature, and peer groups.
•    Maintain sufficient and accurate records per company policy.
•    Participate in training and development of Engineering and Laboratory personnel.
•    Perform other quality system duties (e.g., CAPA, Internal Audits, etc.), as assigned.
•    Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Education / Experience Requirements

•    Bachelor’s degree in life sciences, healthcare administration, engineering or another relevant field; or equivalent practical experience.  
•    A least 3 years of experience in the medical device industry or equivalent experience in a related field is preferred. 
•    Experience with ISO13485, MDD, and FDA quality system regulations.  
•    Experience with Pilgrim SmartSolve software is a plus. 

Specialized Skills / Other Requirements

•    Ability to solve problems creatively and develop quick solutions
•    Strong communication skills.
•    Strong Time Management 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