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Medtronic Senior Clinical Quality Specialist in Mansfield, Massachusetts

Senior Clinical Quality Specialist

Location:

Mounds View, Minnesota, United States

Requisition #:

22000DVG

Post Date:

Aug 01, 2022

Careers That Change Lives

In this exciting role as a Senior Clinical Quality Specialist, you are responsible for assuring that clinical personnel across Medtronic Clinical Research are educated in, and operating within, U.S. and international regulatory requirements and standards, Medtronic standards, and facilitating continuous improvements to processes and procedures. You will determine and develop approaches to solutions to a wide range of difficult problems requiring imaginative, thorough, specific, and consistent thinking. The role has frequent inter-organizational customer contacts and represents the organization in providing solutions to difficult technical issues associated with specific projects.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.To learn more about Inclusion Diversity at MedtronicClick Here (https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html)

Are you an experienced Clinical Study team member who has had opportunity to work on clinical audits, support FDA inspections, and/or manage Corrective and Preventive Action (CAPA)s? Are you skilled at navigating complex study scenarios while maintaining focus on quality and compliance? Have you enjoyed being a Clinical Study Generalist and are looking to Specialize? If any of these questions sound like you, the Corporate Clinical Quality and Compliance team is the place to be!

The Corporate Clinical Quality Compliance (CCQC) is a global group of people working in partnership with global partners. Together with our global partners, we contribute to clinical research excellence by promoting an unmatched proactive compliance-based culture to meet the clinical evidence needs of Medtronics diverse businesses.

Our Mission as the Corporate Clinical Quality Compliance organization is to identify and minimize risk while maintaining flexibility and maximizing resource efficiency, we will:

  • provide proactiveclinical quality and compliance expertise,

  • establish effective and efficient systems and tools,

  • determine and deliver clinical education,

  • drive process improvements

Preferred location: Mounds View, MN, open for remote.

Ability to travel up to 25%.

A Day in the Life

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

  • Supports the completion of audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of new medical devices application.

  • Conducts and performs investigations and ensures conformance to regulations and company standard operating procedures.

  • Performs quality reviews and tracks corrective and preventive actions until closure.

  • May act as an advisor on clinical quality assurance protocol, amendments and/or biological licensing agreements.

  • May provide training on GCP and current regulations for those undertaking clinical studies.

  • Partners with staff in the implementation and maintenance of policies and procedures aligned with relevant global regulations and standards

  • Facilitates implementation of programs designated to increase employee awareness and knowledge of compliance.

  • Acts 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)

  • Helps establish and track quality performance measurements and may support reporting to management

  • Conducts and performs investigations and ensures conformance to regulations and company standard operating procedures.

  • Provide consultation to CAPA owners to facilitate identifying root cause and development of appropriate action plans

Must Have (Minimum Requirements):

To be considered for this role, the minimum requirements listed below must be evident on your resume.

Bachelors degree and minimum of 4 years of clinical research and/or quality, audit/compliance/CAPA experience within the healthcare industry or advanced degree with a minimum of 2 years clinical research and/or quality, audit/compliance/CAPA experience within the healthcare industry

Nice to Have (Preferred Qualifications):

  • Experience working with the clinical study lifecycle (e.g., planning, execution and closeout)

  • Experience with Good Clinical Practices (GCP)

  • Experience with FDA and international regulations (pharmaceutical and/or device, e.g., 21 CFR 812, 50, 54, 56, 820, ISO 13485, ISO 14155) and/or experience in Quality System regulations.

  • Experience with Corrective and Preventive Action (CAPA)

  • Experience working on audits/compliance within clinical/quality/regulatory

  • Knowledge of 21 CFR 803, 806, ISO 14971

  • Experience in clinical quality assurance at Medtronic or within a medical device industry.

  • Experience in project/program management and/or continuous improvements to processes and procedures.

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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Learn more about our benefits at benefits.medtronic.com

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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