Shantel Haynes
Gilroy,CA
Summary
Accomplished Quality Management System professional offering 25 years of experience within the medical device industry.
Adept at establishment of effective QMS infrastructure(s) which embody policies and processes which align with applicable regulatory standards; ultimately ensuring product quality and/or services to most importantly ensure patient safety requirements are consistently met.
Additionally, as as a skilled Certified Quality Auditor (CQA) I have attained an advanced knowledge of regulatory applications such as but not limited to: 21 CFR Part 11/820, ISO 13485, ISO 14971, ISO 17025, ISO 14001, ISO 19001, MDSAP, EUMDR, KDA, China NMPA, JPAL.
Overview
13
13
years of professional experience
Work History
Principal Quality Compliance Specialist
Shockwave Medical
Santa Clara, CA
03.2022 - 10.2023
- Managed >200 Internal & External Audit Compliance for QMS regulations and product quality.
- Monitor global KPI metric reporting ensuring qualty objectives and goals are
- Reviewed contracts for accuracy and ensured they meet corporate objectives while adhering to applicable law and regulation.
- Enhanced customer relationships by overseeing effective "role specific" personnel training programs which significantly reduced customer complaint and scrap rates.
- Support Engineering teams with necessary development strategies for mitigating risks associated with non-conforming product; identify CAPA escalation where deemed required.
- Conducted quarterly audits for environmental management compliance (EMS).
- Development of QMS policies and procedures for Post -Market and/or consumer reporting.
- Manage and maintain Supplier and CAPA system activities; delivery of additional training where deemed fit.
- Consulted with senior management to strategize potential risks and/or legal ramifications. Recommended solutions for compliance issues.
Quality Systems Manager
TE Connectivity / Creganna Medical
San Jose / Campbell , CA
07.2015 - 03.2022
- Scheduled and managed internal audits to verify and maitain compliance with document control procedures.
- Served as a primary contact with regulatory authorities and notified body during external audit reviews.
- Consulted with management regarding non-compliance issues to improve compliance rates.
- Performed regulatory audits on company environmental compliance.
- Facilitated meetings between executive leadership, and department engineers, to discuss compliance matters.
- Supervised and trained team members for annual QMS trainings (best practices in quality assurance regulations).
- Maintained Document Control System updating work instructions, procedures, and associated database.
- Supervised day-to-day workload for Document Control staff.
- Administrative duties as required i.e. evaluations for staff, personnel issues, and office function)
- Monitored product trends and suggested changes.
Document Control Manager
Proteus Digital Health
Redwood City , CA
07.2010 - 07.2012
- Maintained Document Control System, updated work instructions, procedures and associated databases.
- Administered document access and revision rights to personnel to maintain documentation integrity.
- Assisted with inbound and outbound document processes.
- Processed documents for closing.
- Kept documents moving in proper flow by applying strong organizational, planning and multitasking abilities.
- Directed team to deliver accurate and well-written documents.
Education
Associate of Arts - Business Administration
University of Phoenix
Tempe, AZ01-2007
Skills
- Audit Management (ASQ / BSI Certification CQA)
- QMS Compliance Management
- Automated (EQMS) & Document Data Management Systems
- Regulatory Affairs Application
- Risk Management
- Training Program Development
- Project Management
- Process Development
Timeline
Principal Quality Compliance Specialist
Shockwave Medical
03.2022 - 10.2023
Quality Systems Manager
TE Connectivity / Creganna Medical
07.2015 - 03.2022
Document Control Manager
Proteus Digital Health
07.2010 - 07.2012
Associate of Arts - Business Administration
University of Phoenix
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