Shire Jobs

Sr. Quality System Engineer

Date: May 21, 2024

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel : Up to 10%

Requisition ID :10187

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 reports to the Manager of Quality. As an integral member of the Quality team, this position maintains and continuously improves all aspects of the Quality Management System to ensure company and product compliance with ISO 13485, ISO 14971, QSR (21 CFR 820), and MDSAP. In addition, support production and perform product release activities. 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

• 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 the 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.

• Interact and interface with various government agencies, private companies, and consultants (such as CA FDB, US FDA, DEKRA, NSAI etc.) regarding Quality System audits/inspections; and assist with the timely response to any findings.

• Review and evaluate manufacturing records and approve release of finished product.

• Review and approve labels for use for production.

• Review and revise procedures and/or work instructions and route for approval either in paper or in an electronic system such as Agile or Pilgrim

• 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.

• 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 model effects and analysis, and risk controls.

• 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).

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 Teleflex complies.

• Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

• 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.

• 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.

• 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.

• Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate.

• Teleflex 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 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.

#LI-DR1

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.