K. Michael Grier
QA & Regulatory Affairs Engineer
Quality-Regulatory Affairs/ Engineering
Greater Boston Area
Section title
K. Michael Grier's Email Addresses & Phone Numbers
About K. Michael Grier
See Position ExperienceQA & Regulatory Affairs Engineer @ Cross-Section of Current Assigned Roles, Responsibilities and Projects: MAY14 Role Assignment: QA/RA Lead- U.S. Wellspect Healthcare / State Licenses and Permits Management of business License/Permits for state-to-state Drug/DME applications and renewals JUN14 Project: Identification of Regulatory Standards and Associated Quality System Management references Manage site "Essential Requirements Check List"...
See Position ExperienceQA & Regulatory Affairs Engineer @ Cross-Section of Current Assigned Roles, Responsibilities and Projects: MAY14 Role Assignment: QA/RA Lead- U.S. Wellspect Healthcare / State Licenses and Permits Management of business License/Permits for state-to-state Drug/DME applications and renewals JUN14 Project: Identification of Regulatory Standards and Associated Quality System Management references Manage site "Essential Requirements Check List" . Identify method/s to stay current on all versions and applicable US, Canadian, European and CIS standards. Marry these methods with the appropriate internal quality system references. Add date references to a separate document; so update of the Check List is not unnecessarily repeated on a due to regulatory change/s. (Referenced document standards: ISO, EN ISO and EN Standards which apply to use of the “technical document” for EC Declaration of Conformity, EU Device Classification and CMDR- Canadian Medical Device Regulations SOR/98-282 compliance) JUL14 Role Assignment: DCO - District Complaint Officer Division management (DIH Inc.) of worldwide Atlantis Abutments complaints. This includes post market surveillance activities, implementation of robust CAPA’s and cross-functional CAPA guidance to enhance quality system healthiness. In addition, I lead monthly PSC (Product Surveillance Committee) meetings. PSC meetings are attended by management from appropriate site and global functional groups. Complaint metrics are gathered, managed and discussed at the PSC meeting then forwarded for senior executive quality council preview. From May 2014 to Present (1 year 8 months) Waltham, MassachusettsQuality Engineer/Sr QA Compliance Spec @ From March 2010 to May 2014 (4 years 3 months) Principal QC Analyst/Sr QC Analyst @ From February 2008 to July 2009 (1 year 6 months) Sr QC Analyst/ QC Analyst @ From October 2005 to January 2008 (2 years 4 months) Research Associate @ Research associate in Biochemistry /Pharmacology department From 2003 to 2005 (2 years) BostonChemist @ From 2002 to 2004 (2 years) MS, Regulatory Affairs, Health Sciences and Public Policy @ Massachusetts College of Pharmacy and Health Sciences (MCPHS) From 2010 to 2012 Post Baccalaureate, Physical and Biological Sciences @ University of Massachusetts Boston From 2008 to 2009 BS, Molecular Biology and Biochemistry @ SCSU (Southern Connecticut State University) K. Michael Grier is skilled in: FDA, Validation, 21 CFR Part 11, Regulatory Affairs, Regulatory Requirements, GxP, Quality System, FDA GMP, ISO 13485, Quality Auditing, Quality Assurance, Quality Control, CAPA, Change Control, Pharmaceutical Industry, Biopharmaceuticals, GCP, GLP, LIMS
K. Michael Grier’s Personal Email Address, Business Email, and Phone Number
are curated by ContactOut on this page.K. Michael Grier's Work Experience
DENTSPLY International
QA & Regulatory Affairs Engineer
May 2014 to Present
Waltham, Massachusetts
Sanofi
Quality Engineer/Sr QA Compliance Spec
March 2010 to May 2014
Lonza
Principal QC Analyst/Sr QC Analyst
February 2008 to July 2009
Amgen
Sr QC Analyst/ QC Analyst
October 2005 to January 2008
Tufts University, School of Medicine
Research Associate
2003 to 2005
Boston
ArQule
Chemist
2002 to 2004
K. Michael Grier's Education
Massachusetts College of Pharmacy and Health Sciences (MCPHS)
MS Regulatory Affairs Health Sciences and Public Policy
2010 to 2012
University of Massachusetts Boston
Post Baccalaureate Physical and Biological Sciences
2008 to 2009
SCSU (Southern Connecticut State University)
BS Molecular Biology and Biochemistry
About K. Michael Grier's Current Company
DENTSPLY InternationalCross-Section of Current Assigned Roles, Responsibilities and Projects: MAY14 Role Assignment: QA/RA Lead- U.S. Wellspect Healthcare / State Licenses and Permits Management of business License/Permits for state-to-state Drug/DME applications and renewals JUN14 Project: Identification of Regulatory Standards and Associated Quality System Management references Manage site "Essential Requirements Check List" . Identify method/s to stay current on all... Cross-Section of Current Assigned Roles, Responsibilities and Projects: MAY14 Role Assignment: QA/RA Lead- U.S. Wellspect Healthcare / State Licenses and Permits Management of business License/Permits for state-to-state Drug/DME applications and renewals JUN14 Project: Identification of Regulatory Standards and Associated Quality System Management references Manage site "Essential Requirements Check List" . Identify method/s to stay current on all versions and applicable US, Canadian, European and CIS standards. Marry these methods with the appropriate internal quality system references. Add date references to a separate document; so update of the Check List is not unnecessarily repeated on a due to regulatory change/s. (Referenced document standards: ISO, EN ISO and EN Standards which apply to use of the “technical document” for EC Declaration of Conformity, EU Device Classification and CMDR- Canadian Medical Device Regulations SOR/98-282 compliance) JUL14 Role Assignment: DCO - District Complaint Officer Division management (DIH Inc.) of worldwide Atlantis Abutments complaints. This includes post market surveillance activities, implementation of robust CAPA’s and cross-functional CAPA guidance to enhance quality system healthiness. In addition, I lead monthly PSC (Product Surveillance Committee) meetings. PSC meetings are attended by management from appropriate site and global functional groups. Complaint metrics are gathered, managed and discussed at the PSC meeting then forwarded for senior executive quality council preview.
Frequently Asked Questions about K. Michael Grier
What company does K. Michael Grier work for?
K. Michael Grier works for DENTSPLY International
What is K. Michael Grier's role at DENTSPLY International?
K. Michael Grier is QA & Regulatory Affairs Engineer
What is K. Michael Grier's personal email address?
K. Michael Grier's personal email address is g****[email protected]
What is K. Michael Grier's business email address?
K. Michael Grier's business email addresses are not available
What is K. Michael Grier's Phone Number?
K. Michael Grier's phone (**) *** *** 406
What industry does K. Michael Grier work in?
K. Michael Grier works in the Pharmaceuticals industry.
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