Principal Quality Systems CAPA Specialist - Mounds View, MN
Full Time
Minneapolis, MN 55432
Posted
Job description
Careers That Change Lives
In this exciting role as a Prin Quality Systems Specialist (CAPA Specialist) you will have responsibility of the CAPA Program for a new acquisition. You will ensure compliance of the Corrective and Preventative Action (CAPA) process and Medical Device regulations and requirements by working closely with CAPA Board leaders and CAPA Owners in the development of CAPA activities and the rigorous assessment of CAPA documentation. Responsible for ensuring robust CAPA files with root cause determinations, and effective actions. Ongoing analysis and improvement of the CAPA program including CAPA processes, metrics and trends, and training programs.
Cardiac Ablation Solutions
Cardiac Ablation Solutions (CAS) Operating Unit offers cardiac mapping and ablation solutions for arrhythmia management.
A Day in the Life:
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Provide rigor to CAPA investigations, action planning, action implementations and effectiveness.
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Support and guide CAPA Board Leaders and Users regarding the CAPA process, CAPA record content, and CAPA System, Trackwise.
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For investigations in which root cause is not known, work closely with the CAPA owner and CAPA boards to identify key stakeholders, identify key milestones, and develop a timeline of parallel activities intended to determine root cause.
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Support CAPA owners and task owners through commitment, execution, and delivery of milestones for projects.
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Provide guidance on practical execution to CAPA teams.
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Support the development and implementation of Quality System CAPA procedures, CAPA software, and CAPA training programs.
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Provide upper and cross-functional management with regular updates on project status and progress as requested.
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Provide CAS Leadership and CAPA Board Leaders with metrics and reporting on critical aspects regarding the health of the CAPA process.
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Support FDA and Notified Body inspection plans as a CAPA Program Office representative. Activity includes improvement and remediation activities.
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Provide guidance in interpreting government regulations, agency guidelines and Medtronic internal policies in general and specific to CAPA to assure compliance.
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Operate within CFR 21 and ISO-13485 compliant quality system environments
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Additional tasks assigned by the Quality Systems Director
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Responsible for addressing assigned CAPA activities and ensuring that established timelines are met.
Must Have: Minimum Requirements.
To be considered for this role, please ensure the minimum requirements are evident on your resume:
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Bachelor’s Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality
Nice to Have:
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Previous experience in owning and managing CAPA’s and other product performance issues is required.
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Experience effectively managing cross-functional team members.
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Working knowledge of Medical Device and/or Pharmaceutical Regulations (US 21 CFR 820, 210, 211 and 11 and ISO 13485).
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Experience with quality tools and process improvement techniques
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Strong analytical skills. Reliable and timely decision maker (decisions based on relevant information, alternatives, risk).
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Proven experience clearly communicating both verbally and in writing to a multitude of audiences and be able to work in a multidisciplinary team
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Proven influence management skills
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)
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)
Ability to travel within the United States up to 25%.
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