Quality Assurance Medical Device

Contact

ad9g4u@r.postjobfree.com

www.linkedin.com/in/robin- baker-08a8737 (LinkedIn)

Top Skills

Quality Management Systems Quality Assurance & Control Auditing Medical Device Regulations (ISO 13485, 21 CFR 820,

EU MDR, MDSAP, and more)

CAPA Management

Risk Management

Design Controls

Continuous Process Improvement Cross-functional Collaboration Training Program Development

Lean Six Sigma & DMAIC

Data Analysis & Reporting

Change Acceleration Process Leading Through Facilitating

Future State Mapping

Driving Value Through Process & Project Management

Think on Your Feet

Strategic Employment Demand Flow

Advanced knowledge in:

MAP Agile

Documentum

MRCS

Cornerstone LMS

TrackWise

Expense Express

One Source

FactoryWorks

Proficient knowledge of internet and Microsoft Office Applications (Word, Excel, and PowerPoint, Project and Visio).

Certifications

ASQ Certified Quality Auditor

ASQ Certified Biomedical Quality Auditor

Robin Baker

Princ. Quality System Specialist at Medtronic

Accomplished Quality Leader 28+ Years in Medical Devices Expertise in Quality Systems, Process Improvement Auditing, CAPAs, Training ASQ CQA, CQBA Certified

Circle Pines, Minnesota, United States

Summary

Accomplished Quality professional with nearly 40 years of experience, including 28 years in the medical device industry driving compliance and operational excellence. Proven track record of leading quality system management, audits, CAPAs, process improvements, and cross-functional initiatives to ensure products meet the highest standards. Self-motivated collaborative leader skilled at interpreting regulations, managing CAPAs, preparing for external audits and implementing effective training programs. Team player with analytical and strategic mindset known for strong accountability in driving compliance and operational excellence that ensures products meet optimal standards. Seeking opportunities to leverage my expertise in quality to support an organization's commitment to delivering superior products that improve patient (like me) outcomes.

In my time at Medtronic, I went from Quality Inspector of components for CRM to holding Quality Systems leadership roles supporting major product lines for 8 operating units for Cardiovascular Portfolio. Adapted in managing quality through major events like 438 responses, recalls, site shutdowns and product launches.

-Facilitating 70+ audits annually with zero 483s or major non- compliance findings

-Owner of several effective CAPAs, including Enterprise CAPAs

-Maintaining 99.6% training completion for 100+ team members

-Assisted in the development and implementation of Tech Comm requirements traceability verification process for Coronary & Renal Denervation (CRDN), Cardiac Surgery (CS), Peripheral Vascular Health (PVH), and Structural Heart & Aortic (SH&A) IFUs.

-Developed and implemented a training program designed to increase employee awareness and knowledge of compliance policies and manufacturing procedures.

Managing quality records through Heart Valve shutdown, capturing and archiving 200+ type of quality records.

Experience

Medtronic

Princ. Quality System Specialist (Cardiovascular Portfolio)

August 2012 - May 2024 (11 years 9 months) Mounds View MN

Primarily responsible for supporting CVP Technical Communication (Tech Comm) quality systems, audit and compliance, internal training, projects management, CAPAs, and process improvements. Supporting Design Controls, Technical Writing, Editing, Graphics, Translations and eManuals.

Perform complex and diverse quality tasks, providing extensive knowledge and support of a variety of internal systems.

Supports the creation and maintenance, review and approve all CVP Tech Comm QMS procedures, QMS Document and Records Management, Change Control, and Training.

Own/perform CAPA investigations, root cause analyses, corrections, corrective/preventative actions, and verifications of effectiveness.

Former member of the Structural Heart CAPA Board.

Lead or participate in internal audits for other Medtronic facilities.

Lead and facilitate the coordination and preparation for internal and external notified bodies (FDA. TUV, BSI, etc.) audits (typically 70+ annually).

Engage with CAPA Specialists and Internal Audit chairs/coordinators to resolve responses on time.

Lead Tech Comm nonconformance management for Internal and External Audits.

Created and maintained Tech Comm employee’s training requirements/matrix/certifications with an average of 99.6% training completion rate for over 100+ team members.

Cornerstone and GTAT LMS admin experience (creating certifications and pulling reports for audits)

Monitors and analyzes quality metrics to identify areas for improvement and initiate corrective actions.

Present metrics of CAPAs, audit finding, training compliance status quarterly at the all-employee meetings (AEM).

Work with Reliability to ensure risk assessments are performed for all Technical Communications issues, including all translation quality issues with Medtronic Translations.

Support the facilitator for the Quarterly Business Reviews with Medtronic Translations.

I nominate and present the “Quality Spotlight” employee at the quarterly AEM to congratulate and celebrate people on our team that have demonstrated Quality Begins with Me behaviors.

Corporate Quality Systems and Training Coordinator

July 2010 – August 2012 (2 years 1 months) Fridley, Minnesota, United States

Primarily responsible for managing document control for all Medtronic Global/ Corporate Policies, documents and quality records. Manage the Medtronic Corporate Policy website.

Ensure QMS effectiveness and eliminate compliance risk by notifying and monitoring revised policies and processes to the organization.

Represents the organization as a prime internal contact on policy implementation.

Deliver administrative support in all areas for the Corporate Compliance Director and audit group by facilitating and participating in quality projects as needed.

Medtronic

Quality Systems and Training Coordinator (Heart Valves)

2009 - 2010 (1 year)

Spring Lake Park, Minnesota, United States

Primarily responsible for the development, execution and maintenance of the manufacturing operations and site training program. Establish and maintain quality assurance programs, policies, processes, and procedures ensuring

that performance and quality of products conform to established standards and regulatory requirements of Class III devices.

Developed and implemented a training program designed to increase employee awareness and knowledge of compliance policies and manufacturing procedures. Implemented Certified Training Plans and Proficiency Assessments with a risk-based approach.

Successfully represent SLP in business unit quality systems internal and external audits of the Training System resulting in no 483s or Major Non- Compliance from 3rd Party inspections.

Managed the quality records portion of the Heart Valves shutdown; captured, asses and archived over 200 types of electronic and paper quality records.

Quality Compliance Engineering Technician (Heart Valves)

2001 - 2009 (8 years)

Spring Lake Park, Minnesota, United States

Primary responsibility measuring and communicating on the status of the Quality system compliance through assessments and reporting. Assess compliance and effectiveness of Quality System with respect to all relevant regulations, standards, and Corporate Policies.

Maintain the Corrective and Preventive action (CAPA) system at the Spring Lake Park (SLP) facility to ensure corrective/preventive actions are documented, implemented, and measured for effectiveness and are complaint to the quality systems.

Lead and/or participate in Medtronic Internal Quality, Clinical, and Regulatory, and Device Tracking audits.

Lead and facilitate the coordination and preparation for internal and external audits.

Successfully represented the CAPA and the Internal Audit system, and Part 11 compliance during third party and FDA inspections resulting in no 483s or Major Non-Compliance from 3rd Party inspections.

Facilitate and prepare reporting matrix for Quality Business Reviews. Support coordination and creation of presentations, mainly in PowerPoint.

Maintained SLP Quality Manual and Quality Site Map, Part 11 Assessments, Training matrices, and QMS policies, procedures and GMP training.

Sr. Quality Inspector

1997 - 2001 (4 years)

Inspect Components

Education

Bemidji State University

Bachelor of Applied Science in Technology Management, Biomedical Quality

University of Phoenix AAB, Business

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