Jeff Purdy
Minneapolis
Summary
Quality and regulatory professional with over 5 years of experience in supporting QMS and regulatory functions, looking to get back into the Quality and Regulatory field. Proven track record in enhancing compliance and streamlining processes. Eager to leverage past experience to drive team success in regulatory and quality domains.
Overview
7
7
years of professional experience
Work History
Quality Assurance Specialist
NAMSA
Brooklyn Park
07.2019 - 03.2020
- Maintained Non-Conformance and Corrective and Preventative Action (CAPA) Logs, reporting metrics to quality and operational management to ensure compliance
- Oversaw site document change control, analyzing changes to enhance documentation accuracy
- Lead Archivist managing oversight of study and document archives for GLP studies
- Trained staff on Non-Conformance and CAPA procedures, conducting quality reviews to ensure adherence to standards
- Performed Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) Training on all staff, and contracted with hospitals for new hire GDP Trainings
Associate Configuration Assuarance Administrator
Medtronic
Chanhassen
10.2015 - 05.2019
- Oversaw Business site's timely and cost-effective conversion from paper-based documentation system to electronic (agile).
- Served as site, regional and global training function representative for Medtronic's enterprise agile documentation system initiative, gathering feedback from business partners and relaying insights to broader Medtronic team to ensure alignment with business requirements in overall enterprise solution.
- Facilitated the Global Training Sub-Council Working Group, where we developed the training framework supporting Medtronic’s enterprise Global QMS Architecture supporting Medtronic's initiative for operational efficiency.
- Spearheaded migration to electronic tablets for manufacturing procedures, eliminating over 1000 paper procedures that necessitated manual updates, resulting in reduced man hours per change, and overall operational efficiency in change management process
- Performed quality system and process owner reviews, where I ensured internal policies, procedures, and documentation maintained compliance with FDA regulations and global quality standards, resulting in complaint and efficient procedures.
- Process Owner for Training and Document Control, providing feedback to greater Medtronic Team and implementing Global Procedures, as well as continually seeking compliant process improvements site-wide to support operational efficiency.
- Oversaw backroom coordination for QMS management, ensuring effective audit support. Delivered documentation promptly to front room, receiving commendations from auditors for timely support during closing meetings.
- Owned Corrective and Preventative Actions (CAPA)'s correcting and improving deficiencies in Quality System, resulting in every CAPA passing its Effectiveness Check (Effectively corrected the deficiency or identified gap by auditors, management or QMS Team)
- Performed Regulatory Review for Document Changes, ensuring compliance with regulations
- Performed Medical Device Reporting Regulatory Review, utilizing FDA Guidance's.
Regulatory Affairs Intern / Specialist
Acist Medical Systems
Eden Prairie
05.2013 - 09.2015
- Established global shipping matrix process enabling regulatory management to validate matrix additions and confirm device approvals for worldwide compliance.
- Performed FDA Device Change Review, completing file/no-file decisions for the FDA, following FDA guidance on when to submit a new 510(k) or submission, or not.
- Assisted Senior and Principal Regulatory Affairs Specialists in preparing 510(k)'s, maintaining EU Technical Files, and other types of submission documentation around the world (including China, and Japan), to support maintaining and submitting new business medical device approvals
- Executed data migration mapping for transition from paper documentation system to agile electronic documentation system, ensuring comprehensive mapping of all migrated documents
Education
Bachelor of Science - Biomedical And Biological Sciences
Minnesota State University - Mankato
Mankato, MN05.2015
Skills
Regulatory & Quality Compliance
- FDA 21 CFR Part 11, 806, 820
- ISO 13485:2016
- ISO 14971 Risk Management
- Medical Device Directive (MDD)
- GMP / GDP Compliance
- 21st Century Cures Act
Quality Systems & Enterprise Platforms
- Agile PLM
- TrackWise QMS
- SAP ERP
- Enterprise QMS Architecture
- Document Control Systems
Professional Skills
- Audit Preparation, Support, and Performing Audits
- CAPA
- Change Management
- Cross-Functional Leadership
- Global Process Harmonization
- Training Program Development
- Good Documentation Practices
Timeline
Quality Assurance Specialist
NAMSA
07.2019 - 03.2020
Associate Configuration Assuarance Administrator
Medtronic
10.2015 - 05.2019
Regulatory Affairs Intern / Specialist
Acist Medical Systems
05.2013 - 09.2015
Bachelor of Science - Biomedical And Biological Sciences
Minnesota State University - Mankato