Quality Auditor
Teleflex•Durham, NC
•Onsite
About The Position
Teleflex is seeking a Quality Auditor to join our Strategic Compliance department. The successful candidate must possess the ability to analyze and assess quality management systems to ensure compliance and conformance to the intent of the applicable regulations and standards. The ability to interpret regulations and standards, be aware of industry best practice and focus on ensuring safe and effective product outcomes is necessary for this position. This position is based at our Morrisville, NC office.
Requirements
- Bachelor’s degree in technical field required
- Minimum of 5 years of experience in a quality or regulatory role in the pharmaceutical or medical device industries
- Minimum of 2 years of experience performing internal or supplier audits as the lead auditor
- Fluency in English required
- Understanding and application of quality systems
- In depth understanding and interpretation experience for the following regulations and standards: Required: FDA Title 21 CFR 820 QMSR, ISO 13485:2016
- Strong communication and interpersonal skills with a broad spectrum of people from varying backgrounds, education and experience.
- Ability to understand technical operations, processes and validation.
- Critical thinking, logic and analytical skills
- Documentation, organization and time management skills
- Technical writing skills
- Ability to operate with limited supervision within defined parameters
Nice To Haves
- Fluency in Spanish, German and/or Czech desired
- Desired: MHLW No. 169; Ministerial Ordinance
- SOR 98-282; Medical Device Regulations
- TG(MD)R: Therapeutic Goods (Medical Devices) Regulations 2002
- ANVISA RDC 665/2022
- EU MDR 2017/45 European Medical Device Regulations
Responsibilities
- Plan, execute and document internal quality system audits
- Track audit observations and follow up on resolution
- Compile and report audit metrics
- Train and mentor site quality auditors in general quality system auditing practices
- Provide interpretation and consultation to project teams on regulations and standards
- Assist with the development, implementation and maintenance of the corporate auditor training program
- Assist in training of new auditors
- May present educational content and guidance to other functions
- Adhere to and ensure compliance with the Teleflex Code of Ethics, all company policies, rules, and procedures
- Complete other duties and tasks, as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
