# Understanding the 'Compliance Manager' Role

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-03-09
- Length: 21m
- Episode: 309
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-09-understanding-the-compliance-manager-role
- Listen: https://podcast.greenlight.guru/episode/understanding-the-compliance-manager-role

## Summary

Maryann Mitchell, a Solutions Engineer at Greenlight Guru with 15 years of medical device experience, explains the role of a Compliance Manager and the cultural barriers between engineering and quality teams. She details challenges in managing multi-site quality systems, such as right-sizing procedures for sites ranging from 11 to 1,000 employees, and the pain of losing traceability when engineers iterate without documentation. Mitchell contrasts paper-based systems with electronic Quality Management Systems (eQMS), highlighting how eQMS improves audit defense and reduces administrative bottlenecks like lost physical documents.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-09-understanding-the-compliance-manager-role#t=0) Introduction: Maryann Mitchell and Greenlight Guru
- [2:15](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-09-understanding-the-compliance-manager-role#t=135) Maryann's Background and Global Compliance Role
- [3:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-09-understanding-the-compliance-manager-role#t=203) Harmonizing Quality Systems Across Global Sites
- [5:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-09-understanding-the-compliance-manager-role#t=321) Pains of Implementing Quality Management Systems
- [6:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-09-understanding-the-compliance-manager-role#t=396) Cultural Barriers: Engineering Iteration vs. Documentation
- [9:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-09-understanding-the-compliance-manager-role#t=563) Over-Engineering Processes and Audit Defense
- [11:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-09-understanding-the-compliance-manager-role#t=693) Compliance Manager vs. Quality Manager Roles
- [13:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-09-understanding-the-compliance-manager-role#t=788) Paper Systems vs. Electronic Quality Management Systems
- [17:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-09-understanding-the-compliance-manager-role#t=1029) Building Relationships and True Quality Mindset

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- Maryann Mitchell (other)
- Etienne Nichols (other)
- MedTech Excellence (other)
- FDA (other)
- Notified Body (other)
- eQMS (other)
- SharePoint (other)
- Google (other)
- Dropbox (other)
- DocuSign (other)

## Related episodes from other shows

- [215 - Why Aren’t Technical People Leading Drug-Device Audits?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-26-215-why-arent-technical-people-leading-drug-device-audits) (Let's Combinate)
- [205 - Why Less Than 20% of Companies Have Started Quality 4.0](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-11-205-why-less-than-20-of-companies-have-started-quality-4-0) (Let's Combinate)
- [130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management) (Let's Combinate)
- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)
- [Digitizing Quality Management](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2022-08-09-digitizing-quality-management) (The Manufacturing Executive)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-09-understanding-the-compliance-manager-role. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.