Fda Auditor Jobs in Raleigh, NC (NOW HIRING)

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.

   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

   Bachelor's degree in technical field required
   Minimum of 5 years of experience in a quality or regulatory role in the pharmeceutical 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
   Fluency in Spanish, German and/or Czech desired
   In depth understanding and interpretation experience for the following regulations and standards:
       Required:
   FDA Title 21 CFR 820 QMSR
   ISO 13485:2016

       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

   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

INDIVIDUAL CONTRIBUTORS: 

   Commitment to Goals - A strong commitment to achieving goals is essential for personal and team success. It requires taking ownership of tasks, staying focused on priorities, and consistently delivering high-quality work. Being proactive, managing time effectively, and seeking support when needed are critical to meeting deadlines and overcoming challenges. By aligning personal efforts with team and organizational objectives, individual contributors play a vital role in driving results and advancing shared goals.

   Continuous Improvement - Continuous improvement means actively seeking ways to enhance your work, skills, and contributions. It's critical to stay curious, embrace feedback, and look for opportunities to streamline processes or solve problems more effectively. Individual contributors should take initiative to learn from experiences, adapt to change, and apply new knowledge to drive better outcomes. By consistently striving to improve, they add value to their team and support the organization's growth and success.

   Culture and Values - Living our culture and values is essential to fostering a positive, collaborative work environment. Individual contributors demonstrate this by treating others with respect, acting with integrity, and contributing to an inclusive and supportive team culture. It's critical to hold oneself accountable, align actions with shared values, and support the broader mission of the organization. By consistently modeling these behaviors, individual contributors help strengthen the workplace culture and positively influence those around them.

TELEFLEX QUALITY BEHAVIORS:
As a member of the QARA team, you play a critical in our mission to improve the health and quality of people's lives. Below are the quality behaviours that we expect all QARA employees to exhibit every day.

Patient Focused
   We prioritize our patients and users in our decision making. 
   We understand our products and recognize our actions affect product quality. 
   We understand the impact of product quality on user and patient safety. 

Accountable
   We show up prepared and if we say we'll do it, we do. 
   We learn from mistakes and address them quickly.
   We speak up and take responsibility.         

                              
Preventive
   We proactively look for and address things that could go wrong. 
   We speak up when we notice poor quality. 
   We correct poor quality and prevent recurrence.  

Solution Minded
   We bring solutions to identify problems and are open to change.  
   We share and implement ideas to continuously improve. 
   We evaluate fully and investigate to root cause.  

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