Mark Heiberg Cqe Cqa mark.heiberg@bsci.com & & +1 617-689-6000 | ASQ Certified Quality Engineer ASQ Certified Quality Auditor  Quality Systems experience escorting FDA, Brazilian, Korean, and ISO notified body inspectors as well as leading in-house quality systems audits to FDA CFR 21 820, ISO 13485, and ISO 14971.  Extensive experience in a variety of Quality and Manufacturing roles for medical device development, production, and postmarket surveillance.  - Design Control - Document Control - Process Control - Validation - Risk Management - Auditing - Non-conforming Product Control - Supplier Quality

Mark Heiberg Cqe Cqa

ASQ Certified Quality Engineer ASQ Certified Quality Auditor  Quality Systems experience escorting FDA, Brazilian, Korean, and ISO notified body inspectors...

15301 Excelsior Boulevard, Minnetonka, United States

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Mark Heiberg Cqe Cqa’s Emails [email protected]

Mark Heiberg Cqe Cqa’s Phone Numbers 1617689****

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Mark Heiberg Cqe Cqa’s Location 15301 Excelsior Boulevard, Minnetonka, United States

Mark Heiberg Cqe Cqa’s Expertise ASQ Certified Quality Engineer ASQ Certified Quality Auditor  Quality Systems experience escorting FDA, Brazilian, Korean, and ISO notified body inspectors as well as leading in-house quality systems audits to FDA CFR 21 820, ISO 13485, and ISO 14971.  Extensive experience in a variety of Quality and Manufacturing roles for medical device development, production, and postmarket surveillance.  - Design Control - Document Control - Process Control - Validation - Risk Management - Auditing - Non-conforming Product Control - Supplier Quality - CAPA (Corrective and Preventive Actions)

Mark Heiberg Cqe Cqa’s Current Industry Boston Scientific

Mark Heiberg Cqe Cqa’s Prior Industry
Beckman Coulter | Upsher Smith Laboratories | Abbott | Boston Scientific

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Work Experience

Boston Scientific

Quality Engineer

Tue Oct 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Abbott

Quality Engineer

Sun Apr 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Oct 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Upsher Smith Laboratories

Supplier Quality Management Specialist

Sat Jul 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)

Upsher Smith Laboratories

Quality Engineer

Sat Mar 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jul 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)

Beckman Coulter

Senior Scientist Quality Assurance (Postmarket Surveillance)

Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)

Beckman Coulter

Senior Analyst Quality Assurance (Quality Systems)

Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Nov 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)

Beckman Coulter

Scientist Quality Assurance (Operations)

Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)

Beckman Coulter

Scientist Quality Assurance (Development)

Wed Jan 01 1997 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time)

Skills

Languages

FAQ About Mark Heiberg Cqe Cqa

Mark Heiberg Cqe Cqa is located at
15301 Excelsior Boulevard, Minnetonka, United States

Mark Heiberg Cqe Cqa is a
ASQ Certified Quality Engineer ASQ Certified Quality Auditor  Quality Systems experience escorting FDA, Brazilian, Korean, and ISO notified body inspectors as well as leading in-house quality systems audits to FDA CFR 21 820, ISO 13485, and ISO 14971.  Extensive experience in a variety of Quality and Manufacturing roles for medical device development, production, and postmarket surveillance.  - Design Control - Document Control - Process Control - Validation - Risk Management - Auditing - Non-conforming Product Control - Supplier Quality - CAPA (Corrective and Preventive Actions) Boston Scientific

Mark Heiberg Cqe Cqa currently works in the
Boston Scientific

Mark Heiberg Cqe Cqa specializes in
ASQ Certified Quality Engineer ASQ Certified Quality Auditor  Quality Systems experience escorting FDA, Brazilian, Korean, and ISO notified body inspectors as well as leading in-house quality systems audits to FDA CFR 21 820, ISO 13485, and ISO 14971.  Extensive experience in a variety of Quality and Manufacturing roles for medical device development, production, and postmarket surveillance.  - Design Control - Document Control - Process Control - Validation - Risk Management - Auditing - Non-conforming Product Control - Supplier Quality - CAPA (Corrective and Preventive Actions)

Mark Heiberg Cqe Cqa speaks the following languages:
No languages available.

Mark Heiberg Cqe Cqa has prior experience in the following industries:
Abbott , Upsher Smith Laboratories , Upsher Smith Laboratories , Beckman Coulter , Beckman Coulter , Beckman Coulter , Beckman Coulter

Mark Heiberg Cqe Cqa has the following professional experience:
Boston Scientific , Abbott , Upsher Smith Laboratories , Upsher Smith Laboratories , Beckman Coulter , Beckman Coulter , Beckman Coulter , Beckman Coulter .