Amy Tombisammy
Brooklyn Park,MN
Summary
Strategic leader in Quality and Compliance with 20 years of expertise in regulated medical device and pharmaceutical sectors, including 9 years in program and people leadership. Known for translating regulatory requirements into scalable business practices, developing high-performing teams, and driving continuous improvement across global organizations.
Overview
20
20
years of professional experience
10
10
Certifications
Work History
Sr. Compliance/ Audit Program Manager
Medtronic, Inc.
Mounds View, USA
07.2022 - Current
- Planned and hosted external audits and inspections, ensuring compliance with regulatory standards.
- Coordinated internal and external risk assessments, audits, and inspections to ensure adherence to US and international regulations.
- Led development and submission of responses to audit observations from regulatory agencies.
- Analyzed audit data and presented findings to guide business partners in implementing compliance improvements.
- Interpreted regulations and advised stakeholders on compliance for products, processes, and procedures.
- Developed strategies to achieve and maintain Quality System certifications.
- Oversaw inspection management processes, enhancing tools and documentation for efficiency.
- Managed budgets, ensuring resource allocation met program needs efficiently.
Sr. Quality System Program Manager
Medtronic, Inc.
Mounds View, USA
07.2021 - 07.2022
- Approved quality system documents, ensuring alignment with regulatory standards as QMS expert.
- Supported Quality Management System for Cardiovascular Diagnostics & Services (CDS) by leading quality planning and conducting management reviews to enhance system effectiveness.
- Provided comprehensive internal and external audit support for CRM and CDS organizations.
- Contributed to inspection readiness activities that facilitated compliance with standards and regulations for audits.
- Reviewed compliance of quality agreements, FCA-related documents, and CAPA investigations.
- Co-led development of Triage process to enhance CAPA initiation efficiency for CRM and CDS.
Principal Quality System Specialist
Medtronic, Inc.
Mounds View, USA
09.2020 - 07.2021
- Conducted thorough assessments of CAPA activities and documentation to ensure compliance with FDA regulations, ISO 13485, and Medical Device Requirements.
- Managed CAPA Board activities and deliverables, guiding CAPA Board Leaders and Owners to ensure compliance.
- Represented CAPA Program during FDA and Notified Body inspections, driving improvement and remediation initiatives.
- Facilitated development and implementation of Quality System CAPA procedures and training programs, enhancing overall process effectiveness.
- Provided metrics and reports on CAPA process health to support Quality Leadership decision-making.
- Interpreted government regulations and internal policies to ensure compliance with CAPA requirements.
Engineering Manager – Supplier Quality
Medtronic, Inc.
Mounds View, USA
11.2018 - 10.2020
- Oversaw team of Engineers managing 40+ suppliers for Contract and Original Equipment Manufacturing.
- Ensured compliance with design specifications through continuous supplier monitoring and partnerships.
- Reviewed and approved corrective actions as CAPA Board member, addressing supplier quality issues to ensure compliance.
- Collaborated with Supply Management, Operations, Quality, and Product Development to resolve issues effectively.
- Mentored engineers by providing guidance on organizational goals and prioritization strategies.
- Managed budget and operational costs for team functions, optimizing resource allocation.
Principal CAPA Specialist
Medtronic, Inc., Inc.
Mounds View, MN
02.2016 - 10.2018
- Provided subject-matter leadership for the CAPA program, ensuring compliance with FDA regulations, ISO 13485, and internal Quality System requirements. Led CAPA governance activities, supported inspection readiness, and partnered with business leaders to assess process health, identify systemic risk, and drive continuous improvement.
Quality Compliance Supervisor
Perrigo Company
New Hope, USA
08.2013 - 02.2016
- Conducted external customer and regulatory audits, ensuring compliance with applicable regulations.
- Performed internal audits that adhered to site procedures and industry standards.
- Managed Compliance Department addressing unplanned deviations, product complaints, and conducting annual reviews to ensure regulatory adherence.
- Developed departmental KPIs and led QMR activities, demonstrating effectiveness of quality systems and driving continuous improvement.
- Crafted quality responses, including corrective and preventative action plans for identified issues.
- Guided and trained staff to enhance cross-functionality and improve collaboration within the team.
- Supported Quality Engineers' career development aligned with individual goals.
- Oversaw departmental budget management and FTE requests to optimize resource allocation.
Quality Assurance Engineer
Perrigo Company
New Hope, USA
05.2011 - 08.2013
- Led multi-departmental investigations into product quality issues utilizing DMAIC, Fishbone, Kepner Tregoe, and FMEAs.
- Conducted internal quality audits and developed corrective and preventative action plans, improving overall audit readiness.
- Collaborated with senior management to establish Supplier Quality Management and Risk Assessment procedures, enhancing supplier compliance.
- Mentored and trained Perrigo-MN employees on quality objectives, reinforcing alignment with corporate initiatives.
Quality Control Chemist
Perrigo Company
New Hope, USA
04.2010 - 05.2011
- Conducted Quality Control tests on incoming raw materials to ensure compliance with specifications.
- Developed and performed testing protocols for method validation.
- Analyzed chemical properties using advanced laboratory equipment and techniques.
- Supported investigational activities for nonconformances to identify root causes and implement solutions.
- Recorded test results and maintained precise compliance documentation to support regulatory requirements.
Laboratory Chemist
Solvay Pharmaceuticals
Baudette, USA
04.1998 - 06.2002
- Conducted incoming raw material and in-process testing to ensure quality standards for manufacturing operations.
- Trained new personnel on raw material testing procedures to enhance team competency and compliance.
Education
Bachelor of Science - Biochemistry
Minnesota State University, Mankato
Mankato, MN01.1998
Skills
- Audit management and internal auditing
- Compliance analysis
- Quality system development
- Risk assessment and corrective action planning
- Supplier management
- Budget management
- Problem solving
- Cross-functional team leadership
- Data analysis
Certification
Everyday Coaching, Medtronic, 2021
Edge Leadership, Medtronic, 2021
Lead Auditor, AQS Solutions, 2019
PMP Certification Training, Simplilearn, 2018
Cause Mapping, Think Reliability, 2017
Enterprise Excellence, Perrigo, 2015
Lean Sigma, Perrigo, 2013
Kepner-Tregoe, Perrigo, 2011
Certified Trainer, Perrigo, 2010
Certified Analytical Chemist, Solvay, 2000
Accomplishments
Medtronic Mission First Award - FDA For Cause Inspection of CRM
Timeline
Sr. Compliance/ Audit Program Manager
Medtronic, Inc.
07.2022 - Current
Sr. Quality System Program Manager
Medtronic, Inc.
07.2021 - 07.2022
Principal Quality System Specialist
Medtronic, Inc.
09.2020 - 07.2021
Engineering Manager – Supplier Quality
Medtronic, Inc.
11.2018 - 10.2020
Principal CAPA Specialist
Medtronic, Inc., Inc.
02.2016 - 10.2018
Quality Compliance Supervisor
Perrigo Company
08.2013 - 02.2016
Quality Assurance Engineer
Perrigo Company
05.2011 - 08.2013
Quality Control Chemist
Perrigo Company
04.2010 - 05.2011
Laboratory Chemist
Solvay Pharmaceuticals
04.1998 - 06.2002
Bachelor of Science - Biochemistry
Minnesota State University, Mankato