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Sr Quality Systems Specialist (CAPA)

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Quality
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19000N5F Requisition #
Careers That Change Lives
In this exciting role as a Senior Quality Systems Specialist you will have responsibility for Corrective and Preventive Action (CAPA) processes.  Serves as a subject matter expert and provides guidance on CAPA.  Works closely with CAPA owners and CAPA Board Members in the development of CAPA activities and the rigorous assessment of CAPA documentation.  In addition, support internal/external audit(s) and other Quality Management Systems activities.
 
CVG
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
 
CORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat
structural defects of the heart.
 
A Day in the Life
Responsibilities include but are not limited to the following:

Provides continuous and rigorous assessment of CAPA activities and documentation to assure compliance with CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements through the review of CAPA records at critical phases.
Supports the CAPA process at the CVG, CSH and Site level as follows:
Supports and mentors CAPA Owners, CAPA Board Members and CAPA Board Chairs regarding the CAPA process, CAPA best practices, CAPA record content, and CAPA software tools.
Supports CAPA Board Chairs and CAPA Board Members with metrics and reporting on critical aspects regarding the health of the CAPA process.
Manages/facilitates CAPA Board meeting activities and performs CAPA Specialist role.
Completes tasks assigned in support of CVG CAPA Council, CSH CAPA sub Council, and/or Quality Systems Management.
Facilitates/supports the development, implementation, maintenance, training and continuous improvement of the Quality System CAPA procedures, CAPA software, and CAPA training programs.
Supports audit/inspection preparation, execution, and post audit/inspection activities including FDA, TuV, NSAI, BSI, etc. as well as internal audits
Supports implementation of quality objectives and plans to ensure that employees are involved in integrating quality into their processes to meet quality objectives.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Co-ordinates legal requests in support of government investigations or litigations.
Ensures the quality assurance programs and policies are maintained and modified regularly.
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Participates in and may lead projects related to continuous improvement, utilizing root cause methodologies (fishbone diagram, DMAIC, etc.).
Performs other related duties as assigned.

 

Must Have: Minimum Requirements

 

To be considered for this role, please ensure the minimum requirements are evident on your resume.

  • Bachelor’s degree required

  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

  • Experience in medical device, pharmaceutical and/or a comparable regulated environment.

  • Experience reviewing technical documentation.

  • Experience working with non-conformances, corrective and preventive action reports.

  • Understanding of the following: 

    • FDA 21CFR parts 820 and 11

    • ISO 13485

    • ISO 14971

    • Medical Device Directive

    • Canadian Medical Device Regulation

    • Japanese PAL regulation

    • Other applicable Harmonization Standards that apply to medical devices and instrumentation.

  • Experience in external inspections by regulatory bodies.

  • Experience in a matrix organization.

  • Influence management skills; ability to work constructively across all functions of the organization as well as external customers.

  • Strong written and verbal communication skills.

  • Strong analytical and decision-making skills.

  • Project and time management skills.

  • Experience with quality tools and process improvement techniques.

  • Knowledge of effective root cause investigation, corrective and preventive action planning, execution, and verification of effectiveness techniques.

  • Technical project management or quality engineering experience

  • Ability to educate people in Quality Systems and exercise good judgement

 

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)

 

Travel may be required (less than 10%)

 

 

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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