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Medtronic, Inc.

Our medical technologies help make it possible for millions of people to resume everyday activities, return to work, and live better, longer. We're able to do this with the help of some very special people around the world: 38,000 dedicated employees who share a passionate purpose to improve lives, thousands of medical professionals who share their insights and ideas, and hundreds of advocacy associations that help us share information so people with debilitating diseases know relief is... Read More

Address      710 Medtronic Pkwy, Minneapolis, MN, United States
Website      www.medtronic.co.in/
Holding      No Holding Details

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Clinical Quality Specialist

 Position Description

The Clinical Quality Specialist is responsible for assuring that clinical personnel across Medtronic Clinical Research Institute (MCRI) are educated in, and operating within the international regulatory requirements and standards, Medtronic standards, and facilitating continuous improvements to processes and procedures.  This will be accomplished through bringing the clinical organizations into a quality systems model of operation that will bring improved business processes and ensure that quality is built into the clinical process.

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.

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.
• Assists in planning and conducting internal audits with low to medium risk and complexity per all applicable internal audit procedures and guidance’s.
• Assists in analyzing internal audit results and quality/compliance risks for Management Reporting.
• Reviews responses from internal or external audits and may assess adequacy of responses.
• Ensures that internal audit follow-up and support is established.
• Ensures action plans are documented, implemented, and effective.
• Helps coordinate on-time closure of actions.
• May support external inspections at the sponsors, site, or CRO/Core Lab, and follow-up on actions.
• Partners with superiors to ensure escalation of compliance issues to management and/or the business unit as applicable.
• May report on internal audit, CAPA and performance 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.
• Perform additional duties in line with company business requirements.

Basic Qualifications

EDUCATION REQUIRED
• Bachelor’s degree (technical or non-technical)
• Knowledge and experience of international regulations (pharmaceutical and/or device, e.g. ISO 14155) and/or experience in Quality System regulations.
• Proficiency in Spanish and English required (reading, writing and speaking)

YEARS OF EXPERIENCE
• 4+ years experience (or 2+ years 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
• High attention to detail and accuracy
• Strong proficiency in MS Office, including PowerPoint, Excel and Word.
• Excellent organizational skills and demonstrated ability to handle multiple tasks accurately and efficiently
• Prior experience in fast-paced office with multiple priorities.
• Must be customer service oriented with strong interpersonal skills
• Excellent presentations skills.
• Responsive, action-oriented and innovative problem solver

Desired/Preferred Qualifications

• Knowledge of 21 CFR 812, ISO 13485, ISO 14971

Physical Job Requirements

• Ability to travel up to 40%
• Travel with colleagues and manager as requested.
• May require international travel.
• Keyboard up to 8 hours a day
• Sit/Walk/Stand up to 8 hours a day
• Lifting up to 25 lbs.
• 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.

Other Job Information

Vacancy type:

Full Time

Contact Mode:

not provided

Fax:

+1-763-5144879

Contact Name:

not provided

Job Duration:

not provided

Phone:

+1-763-5144000

Email:

www.medtronic.com

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