Alan Mackinnon
Principle Consultant & Owner at Med-Device Consulting, Inc. | Greater Pittsburgh Region
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Alan Mackinnon is a seasoned Quality Assurance Professional with nearly three decades of experience in the medical device industry, currently serving as the Principal Consultant and Owner at Med-Device Consulting, Inc. His extensive background in developing and directing strategic Quality Systems improvements has positioned him as a go-to expert for organizations navigating the complexities of regulatory compliance and quality assurance. Alan's innovative and process-driven approach has consistently yielded successful outcomes, particularly in addressing critical issues such as FDA 483 observations and Consent Decrees.
One of his recent key projects involved leading a comprehensive remediation effort for Intuvie LLC in Natick, MA. As the Lead Consultant from October 2023 to July 2024, Alan spearheaded a thorough Corrective and Preventive Action (CAPA) investigation in response to a nonconformance identified by the FDA. His expertise in Root Cause Analysis enabled him to develop a robust action plan that effectively addressed the 483 observation, ensuring that the client not only met regulatory expectations but also enhanced their overall quality management system.
Alan's proficiency in quality auditing, lean manufacturing, and regulatory affairs is complemented by his deep understanding of ISO standards, including ISO 14971 and ISO 9000. His commitment to best practices, such as Statistical Process Control (SPC) and the DMAIC methodology, allows him to implement sustainable improvements that drive operational excellence. As a diligent business leader and team-oriented consultant, Alan Mackinnon continues to empower clients in the medical device sector to achieve compliance and foster a culture of quality that supports their long-term success.
Principle Consultant & Owner at Med-Device Consulting, Inc. in June 2022 to Present
Sr. Director Global Quality (Manufacturing & Supply Chain) at Omnicell in January 2019 to May 2022
Supplier Quality Director at Philips Sleep and Respiratory Care in June 2016 to January 2019
Principle Consultant and Owner of Barrington Medical Device Consulting at Barrington Medical Device Consulting in June 2011 to June 2016
Global Director of Supplier Quality at Fenwal, Inc., a Fresenius Kabi Company in November 2008 to May 2011
Group Manager of Supplier Quality at Beckman Coulter in November 2004 to October 2008
Manufacturing Quality Assurance Manager at Beckman Coulter in May 2003 to November 2004
Staff Technical Support Manufacturing Engineer at Beckman Coulter in November 1994 to May 2003
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FDA
ISO 13485
CAPA
Design Control
Quality System
Medical Devices
Quality Auditing
Supplier Quality
Validation
CQE
ISO
FMEA
GMP
SPC
Lean Manufacturing
Root Cause Analysis
ISO 14971
V&V
21 CFR Part 11
Six Sigma
Continuous Improvement
Minitab
Quality Management
Change Control
Quality Assurance
Cross-functional Team Leadership
DMAIC
Design of Experiments
Iso 9000
Quality Control
GxP
Sop
21 CFR
Computer System Validation
Calibration
SOP
R&D
Process Simulation
ISO 9000
Regulatory Affairs
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Discover more about Med-Device Consulting, Inc.What is Alan Mackinnon email address?
Email Alan Mackinnon at [email protected]. This email is the most updated Alan Mackinnon email found in 2026.
What is Alan Mackinnon phone number?
Alan Mackinnon phone number is +18472741552 and +12245670657.
How to contact Alan Mackinnon?
To contact Alan Mackinnon send an email to [email protected]. If you want to call Alan Mackinnon try calling on +18472741552 and +12245670657. (updated on October 30, 2024)
What is Alan Mackinnon net worth?
Alan Mackinnon has an estimated net worth of $750,000 to $999,999
What company does Alan Mackinnon work for?
Alan Mackinnon works for Med-Device Consulting, Inc.
What is Alan Mackinnon's role at Med-Device Consulting, Inc.?
Alan Mackinnon is Principle Consultant & Owner
What industry does Alan Mackinnon work in?
Alan Mackinnon works in the Medical Equipment Manufacturing industry.
Alan Mackinnon Email Addresses
Alan Mackinnon Phone Numbers
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