Senior Quality System Engineer
Teleflex

Job Info

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Expected Travel: Up to 10%

Requisition ID: 9388

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 - The Interventional Urology business unit of Teleflex is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our flagship product, the UroLift® System, is the #1 minimally invasive procedure in the U.S. for treating an enlarged prostate, also called Benign Prostatic Hyperplasia, or BPH.* It is a proven approach that does not require heating, cutting, or destruction of prostate tissue.1 Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

*U.S. 2022 estimates based on US Market Model 2022-24 (5-17-22 FINAL), which is in part based on data provided by Symphony Health PatientSource® 2018-21, as is and with no representations/warranties, including accuracy or completeness.
1. Roehrborn, Can J Urol 2017

Position Summary

The Senior Quality Systems Engineer provides support for quality systems,
including but not limited to Risk Management and software development and
validation. As an integral member of the Quality team, this position maintains and
continuously improves all aspects of NeoTract's Quality Management System to
ensure company and product compliance with ISO 13485, ISO 14971, QSR (21
CFR 820), and MDSAP. This position requires exceptional knowledge of national
and international quality system requirements, excellent organizational skills, and
the ability to perform at high levels in a fast-paced, dynamic environment.

Principal Responsibilities

• Oversee the Risk Management program with an emphasis on compliance
with regulatory requirements, ISO 14971, continuous improvement,
system effectiveness, and efficiency to meet the current and future needs
of the Company.
• Maintain Risk Management files and ensure they are complete and
accurately reflect Risk Management activities.
• Partner with Risk Management owners to ensure various Risk
Management elements are adequately documented and addressed while
ensuring timely completion of all Risk Management activities, including
periodic and situational reviews.
• Provide quality guidance and participation in conducting risk management
activities, including hazard identification, hazard analysis, failure mode
effects and analysis, and risk controls.
• Measure, monitor, track, and report Quality System Metrics to ensure
system effectiveness and efficiency; and implement updates/changes as
necessary to meet changing business needs.
• Develop and issue reports to ensure NeoTract's Leadership Team is
informed on the performance of the Quality Systems and team members
are aware of their deliverables within the Quality System at all times.
• Participate in Management Review meetings and assist in gathering,
preparing, analyzing, and presenting data to Executive Leadership.
Form
Document No.:
SOP10289-02
Job Description
Revision:
B
Page:
2 of 4
CONFIDENTIAL REFERENCE ONLY - Unless stamped CONTROLLED COPY in red ink.
• Interact and interface with various government agencies, private
companies, and consultants (such as CA FDB, US FDA, NSAI, etc.)
regarding Quality System audits/inspections; and assist with the timely
response to any findings.
• Oversee quality system improvements related to the product and nonproduct
software development/software validation program and partner
with cross-functional teams to ensure software is appropriately assessed
and qualified prior to use.
• Monitor and report both corporate and departmental quality objectives,
metrics, and goals.
• Promote and ensure companywide quality system compliance and
awareness with all applicable national and international standards and
regulations.
• Partner with cross-functional teams to foster teamwork and strive in
finding win-win solutions that balance the day-to-day business needs with
quality/regulatory compliance.
• Take a lead role in department specific initiatives and projects as
assigned.
• 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 of Science in Engineering, Technical or Life Science discipline;
or equivalent experience.
• At least 7 years of experience in Quality Systems and/or Quality
Engineering with a minimum of 5 years in the medical device industry.
• Exceptional knowledge of national and international quality system
requirements (e.g. QSR, ISO 13485, MDSAP) and related ISO/EN
standards.
• Strong written, oral, interpersonal, analytical, problem-solving skills; and
statistical application experience.
• Excellent level of organizational skills and the ability to multitask while
ensuring a high level of attention to detail.
• Strategic yet hands-on when needed with a high degree of energy and
drive, and the ability to seek function and process improvements
continually.
• Open and direct communication style and a vision for continuous
improvement and excellence.
• Experience with Class II and/or III sterile devices (preferred).
• Ability to travel up to 10%. Overnight domestic and/or international travel
may be required.

Specialized Skills / Other Requirements

Responsible for performing all duties in compliance with FDA's Quality System
Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other
international regulatory requirements with which NeoTract complies.
Language and Verbal Skills:
Individual must have excellent verbal and written communication skills and a
demonstrated ability to communicate clearly and professionally.
Math Skills:
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in complicated, advanced
engineering or mathematical formats.
Analytical and Reading Skills:
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to analyze a variety of technical instructions in mathematical or diagram form and
interpret various abstract and concrete variables. Ability to read technical and clinical
literature and documents and extract important concepts.
Physical Requirements:
The physical demands and work environment described here are representative of those
an employee encounters while performing the essential functions of this job. Reasonable
accommodations may be made to enable individuals with disabilities to perform the
essential functions.
While performing the duties of this job, the employee is regularly required to sit, stand,
walk, talk and hear; up to 8 hours per day. The employee is regularly required to lift and
carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also
involve daily keyboard data entry. Specific vision abilities required by this job include
close vision.
Work Environment:
Most work is performed in an office-like setting. The noise level in the environment is
usually low to moderate.

Safety:
NeoTract is committed to the health and safety of our employees. We expect that all
employees will perform their responsibilities while maintaining a safe, cooperative, and
productive work environment, thus ensuring the health and safety of themselves and
others.

The pay range for this position at the commencement of employment is expected to be between $140,000- $150,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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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: 877-880-8588 or Talent@Teleflex.com.

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.

This job has expired.