Senior Quality Auditor

Expected Travel

More than 50%

376

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

Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

The scope of this position will evaluate corporate quality systems for compliance to regulations, standards, corporate policies, and procedure as well as determine whether the quality system is deployed effectively throughout the company.

• Corporate Auditor for quality system process based auditing.
• Train and mentor site auditors in general auditing practices and standards.
• Complete site Corporate Compliance documents for Lead of Corporate Compliance approval.
• Track audit observations to completion.
• Other duties as assigned.

• Bachelor’s Degree
• 5 or more years experience in a regulatory, quality or operations environment in either a pharmaceutical or medical device industries.
• Knowledge of medical device classfications and compliance requirements.
• Lead Auditor certification from 3rd party.
• Must be fluent in English – Bilingual a plus (at least one other language, German, Spanish, Czech)

• Understanding and application of quality systems
• Understanding of following applicable regulations and standards
• ISO 9001 Quality Management System — Requirements
• ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes
• ISO 14971 Medical Devices — Application of Risk Management to Medical Devices
• Title 21 CFR Part 820 Quality System Regulation Medical Device Directive 93/42/EEC as amended
• Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)
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• Brazil ANVISA Medical Device Regulations
• Canadian Medical Device Regulations SOR/98-282
• Japan Pharmaceutical Affairs Law — Minister of Health, Labor and Welfare (MHLW) — Ministerial Ordinance 169
• ISO 11135-1 Sterilization of Health Care Products — Ethylene Oxide Part 1
• ISO 11135-2 Sterilization of Health Care Products — Ethylene Oxide Part 2
• Strong communication and personal skills interfacing with a broad spectrum of people with varying backgrounds, education and experience
• Ability to understand technical operations, processes and validation
• Proficient in MS Office Suite
• Logic, research, analytical and problem solving skills.
• Documentation, organization and time management skills.
• Operates within a limited latitude for actions/decisions on day-to-day activities.
• Technical writing 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: .