Stacey Orvik
Principal Clinical Quality Assurance Specialist at Boston Scientific | St Paul, Minnesota, United States
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Stacey Orvik serves as the Principal Clinical Quality Assurance Specialist at Boston Scientific, where she leverages her extensive experience in the medical device industry to ensure compliance and uphold the highest standards of quality assurance. In her current role, Stacey is pivotal in managing the vendor audit program for Rhythm Management (RM), which encompasses the meticulous planning, scheduling, and execution of vendor audits. Her expertise in conducting thorough internal and vendor audits is complemented by her adeptness in managing the RM Clinical Approved Vendor List (AVL), where she addresses vendor issues and escalates concerns as necessary to maintain compliance with regulatory standards.
Stacey's responsibilities extend beyond auditing; she meticulously documents audit observations and ensures that appropriate corrective actions are implemented, reinforcing a culture of continuous improvement within the organization. Her proficiency in Corrective and Preventive Action (CAPA) processes is crucial in identifying root causes and preventing recurrence of issues, thereby enhancing overall product quality and patient safety.
With a strong foundation in regulatory requirements, including 21 CFR Part 56 and 21 CFR Part 54, Stacey is well-versed in the intricacies of clinical quality assurance. Her technical skills, such as proficiency in Microsoft Excel and experience with bioassays and cell culture techniques, further enhance her ability to analyze data and drive informed decision-making. As a dedicated QA professional, Stacey Orvik exemplifies a commitment to excellence in clinical quality assurance, ensuring that Boston Scientific continues to deliver innovative and safe medical devices to healthcare providers and patients worldwide.
Principal Clinical Quality Assurance Specialist at Boston Scientific in August 2021 to Present
Senior Clinical Quality Specialist at Boston Scientific in April 2019 to August 2021
Medical Device Auditor (Client Manager) at BSI in September 2017 to April 2019
Quality Assurance Specialist at Bio-Techne in August 2016 to September 2018
Research Associate III, team lead at Bio-Techne in March 2004 to August 2016
Research Assiciate I at Parker Hughes Institute in July 2003 to February 2004
Junior Scientist at University of Minnesota in May 2000 to July 2003
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Microsoft PowerPoint
Microsoft OneNote
Windchill
Excel
Microsoft Outlook
Good Manufacturing Practices (GMP)
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Nonconformance
Clinical Investigator Site Audits
Medical Device Regulation (MDR)
Certified Lead Auditor
ANVISA
TG(MD)R Sch 3
MHLW MO169
ISO 14155
21 CFR Part 11
Master Control
Microsoft Office
Microsoft Excel
Microsoft Word
Regulatory Affairs
ISO 14971
Good Documentation Practices
Calibration
SOP Authoring
Good Manufacturing Practice (GMP)
DNA Extraction
Polymerase Chain Reaction (PCR)
Laboratory Skills
Tissue Culture
Aseptic Technique
Team Leadership
Teamwork
IVDD
Medical Device Directive
MDSAP
Internal Audits
Auditing
Vendor Audits
21 CFR Part 56
21 CFR Part 54
21 CFR Part 50
21 CFR Part 812
21 CFR Part 820
U.S. Title 21 CFR Part 11 Regulation
ELISA
Cell Culture
Bioassay
GMP
Animal Work
Western Blotting
Bacterial Culturing
Histology
Silver Staining
ECL
DNA extraction
Gel Electrophoresis
Corrective and Preventive Action (CAPA)
Complaint Investigations
Medical Review Board
ISO 13485
ISO 9001
In Vitro Diagnostics (IVD)
Internal Audit
Standard Operating Procedure (SOP)
Technical Documentation
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Discover more about Boston ScientificWhat is Stacey Orvik email address?
Email Stacey Orvik at [email protected] and [email protected]. This email is the most updated Stacey Orvik email found in 2026.
What is Stacey Orvik phone number?
Stacey Orvik phone number is +16128675363 and +12188867683.
How to contact Stacey Orvik?
To contact Stacey Orvik send an email to [email protected] or [email protected]. If you want to call Stacey Orvik try calling on +16128675363 and +12188867683. (updated on October 29, 2024)
What company does Stacey Orvik work for?
Stacey Orvik works for Boston Scientific
What is Stacey Orvik's role at Boston Scientific?
Stacey Orvik is Principal Clinical Quality Assurance Specialist
What industry does Stacey Orvik work in?
Stacey Orvik works in the Medical Equipment Manufacturing industry.
Stacey Orvik Email Addresses
Stacey Orvik Phone Numbers
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