Medtronic Hiring for Clinical Quality Specialist – Mumbai at Mumbai, Maharashtra Full Time

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.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

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

Must Have: Minimum Requirements

Bachelors degree in Science

4 years experience (2 years experience with a M.S. degree) directly supporting clinical research within a regulated environment, or other relevant quality experience in a regulated environment.

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

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

Nice to Have

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

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. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)