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JOB TITLE: Clinical Quality Specialist

BUSINESS TITLE: Clinical Quality Compliance Specialist

BUSINESS UNIT: Corporate Clinical Quality and Compliance

POSITION DESCRIPTION:

The Clinical Quality Specialist is responsible for assuring that clinical personnel across Medtronic are educated in, and operating within, U.S. and international regulatory requirements and standards, Medtronic standards, and facilitating continuous improvements to processes and procedures.

The Clinical Quality Specialist works under general supervision, following established procedures, and provides solutions to a variety of compliance problems of moderate scope and complexity. Work is reviewed for soundness of judgment and overall adequacy.

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POSITION RESPONSIBILITIES:

· Ensure personal understanding of all quality policy/system items that are applicable. Follow all work/quality procedures to ensure quality system compliance and high quality work

· Provide review of clinical quality system policies and procedures aligned with relevant global regulations and standards

· Helps Identify opportunities for clinical quality process improvement initiatives

· Partners with superiors to ensure escalation of compliance issues to management and/or the business unit as applicable

· Assists staff in gathering and reporting CAPA metrics

· Assists in tracking performance measurements

· May provide consultation to CAPA owners to facilitate identifying root cause and development of appropriate action plans

· May act as an advisor on clinical quality assurance issues regarding various aspects of the clinical study phases (e.g. patient informed consent forms, investigational plans and amendments)

· May partner with Clinical Quality Training Specialists to facilitate Good Clinical Practices (GCP) training for Medtronic personnel

· May assist with department SOP/compliance training for Medtronic personnel

· Assists department personnel with documenting compliance issues such as SOP deviations and CAPA responses

· Participates in process improvement initiatives

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BASIC QUALIFICATIONS:

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EDUCATION REQUIRED:

· Bachelor’s degree (technical or non-technical)

YEARS OF EXPERIENCE:

· 2 years experience (no experience with a M.S. degree) directly supporting clinical research within a regulated environment, or other relevant quality experience in a regulated environment.

SPECIALIZED KNOWLEDGE REQUIRED:

Knowledge and experience of international regulations (e.g., CFDA Order No. 25, India MDR, ISO 13485, ISO 14155) and/or experience in Quality System regulations.

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DESIRED/PREFERRED QUALIFICATIONS (optional):

· Knowledge of ISO 14971 and other international regulatory agency requirements.

· High attention to detail and accuracy

· Able to manage multiple tasks

· Strong interpersonal skills, ability to work with teams and be a self-initiator

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PHYSICAL JOB REQUIREMENTS:

· Ability to travel up to 40%

· The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform 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 be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.