Kristen Grumet Email and Phone Number
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Nine years of FDA experience as a Field Investigator specializing in the area of medical devices, fifteen years of consulting experience specializing in the area of medical device quality management system remediation and certification, and over five years of industry experience with LifeScan and Intuitive Surgical. With a deep understanding of the medical device regulations and FDA's expectations as well as extensive experience with implementing these requirements, I bring a balanced, practical approach to working with clients in my role as a medical device consultant. Career highlights include:-Member of FDA Design Control Inspection Strategy (DCIS) Team responsible for development and implementation of the DCIS questionnaire used during FDA medical device inspections, and FDA Pacific Region Design Control Training Cadre.-Phase II certified performance auditor in the area of medical devices.-Member of the first cadre of certified medical device investigators in FDA history.-Member of FDA foreign inspection cadre for 6 years; conducted numerous medical device inspections in Europe.Presenter at numerous FDA/industry design control workshops and ASQ seminars.Specialties: auditing, business writing, customer relations, executive management, leadership,
Greenleaf Health Inc.
View- Website:
- greenleafhealth.com
- Employees:
- 38
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Senior Vice President, Regulatory ComplianceGreenleaf Health Inc.Gig Harbor, Wa, Us
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Senior Vice PresidentEliquent Life Sciences Jul 2018 - PresentGig Harbor, Washington, United States -
Senior Vice President, Regulatory ComplianceGreenleaf Health Inc. Jul 2018 - PresentWashington D.C. Metro Area
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Executive Director, Nsf Health Sciences Medical DevicesNsf International Jul 2014 - PresentHome-Based, San Jose, Ca- Helps manage key sectors of the global NSF Health Sciences business to achieve business plans.- Provides expertise / identify resources to deliver high quality services to meet client needs.- Manages projects to assure high quality performance and deliverables.- Performs quality management system audits and remediation activities to meet client needs. -
Director Regulatory ComplianceIntuitive Surgical Inc. Nov 2012 - Jun 2014Sunnyvale, CaManaged Intuitive Surgical’s corporate internal audit, field action, and complaint management functions, as well as the company’s general compliance activities as follows:• Managed a team of internal auditors in performing internal quality system audits and assisting in development and follow up of associated corrective action plans for Intuitive Surgical’s domestic and international sites.• Managed a team of field action specialists to conduct field actions and to improve processes and responsiveness related to product recalls.• Managed a team of complaint specialists and analysts in performing complaint investigations and submitting MDR/vigilance reports.• Managed the product investigation and escalation process for product quality issues.• Hosted regulatory and notified body audits and helped to develop associated corrective actions plans and responses. .
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DirectorQuintiles Consulting Sep 2006 - Nov 2012Assists the Vice President, Medical Device Quality Systems and Validation Services, with management of the medical device program.Works with clients in the medical device, biologic, and biotechnology industries to develop quality assurance and regulatory strategies for compliance with FDA regulations by:Conducting assessments of client studies, procedures, and programs to determine compliance.Assisting with development and implementation of quality systems and validation programs.Developing and implementing corrective action plans to address deficiencies.Presenting GMP/QSR and FDA Inspection Preparedness training.Developing quality policies and procedures.Representative projects have included:Partnering with a medical device manufacturer to remediate their quality system in support of third party certification required by a consent decree. Provided project management and executive oversight in the definition and implementation of a quality system that addressed all previously identified compliance gaps in all subsystems at the manufacturing sites and assured applicability and roll-out to other medical device sites under the corporate umbrella. Provided guidance and support in managing relations and communication with the district FDA office and CDRH. Working with a company, in anticipation of legislation that would require FDA regulation of their products, to identify common expectations for all quality systems based on currently accepted standards, assessed the company's ability to meet these expectations at a general level, and provided an action plan for next steps in establishing a quality system that would meet both the company's business needs as well as anticipated regulatory expectations. -
Manager Quality Systems Compliancesenior Quality Engineer2006 Lifescan Inc Sep 2002 - Sep 2006Managed LifeScan's corporate Quality Systems Compliance department, including activities for the areas of internal audits, management action plan, and inspection readiness programs.Managed a staff of five Regulatory Compliance Specialists on the performance of internal audits and appropriate corrective actions at all LifeScan manufacturing sites.Managed management controls systems, including activities for the areas of management responsibility, quality audits, and training.Implemented or modified systems to address changing regulations or industry standards.Tracked effectiveness and took corrective action on quality issues.Recommended issue resolution to senior management for significant capability and compliance issues.Developed, coordinated, and participated in meetings and presentations to executive management regarding LifeScan's quality system issues, including quarterly management reviews.Identified and implemented opportunities for improvement in all areas of LifeScan's quality system.Provided advice to process owners on interpretation and practical application of regulations.Assisted in third party audits as Subject Matter Expert for management controls and general quality system issues by providing organizational support.Led the quality subsystem team leaders in identifying and aligning goals with J&J strategic imperatives and LifeScan goals and objectives, by tracking and resolving quality system issues and optimizing linkages between quality system areas.
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Associate Director Of Quality SystemsQuintiles Consulting Jan 1997 - Jan 2002Worked with clients in the pharmaceutical, medical device, biologic, and biotechnology industries to develop quality assurance and regulatory strategies for compliance with FDA regulations. Performed QSR/mock FDA inspections at a condom and medical examination glove manufacturer who had received a Warning Letter following a violative FDA inspection. The purpose of the mock inspections was to determine the extensiveness of the violations and therefore included a number of sites involved in testing and manufacture. Mock FDA-483 findings were presented, along with criticality assessments and recommendations for correction. The corrective action plan was successfully presented to officials at CDRH, thereby precluding the need for further regulatory action by the agency. Presented a series of general and subsystem-specific QSR training sessions to a large in vitro diagnostic manufacturer under the conditions of a consent decree. The training was presented to all levels of management as part of the company's corrective action plan.Performed GCP audits of pharmaceutical clinical studies sponsored and monitored by Quintiles sites located in the United States, Europe, Asia, and Africa.
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Investigator, Medical Device SpecialistU.S. Food And Drug Administration Jan 1989 - Jan 1997Was member of FDA Design Control Inspection Strategy (DCIS) Team and FDA Pacific Region Design Control Training Cadre, which was responsible for development and implementation of the DCIS questionnaire used during FDA medical device inspections.Phase II certified performance auditor in the area of medical devices; evaluated auditing skills of Phase I investigators and their knowledge of the medical device regulations.Educated industry in new Quality System Regulation.Inspected medical device manufacturers to ensure compliance with the Quality System Regulation, and conducted numerous medical device inspections in Europe.Documented and developed numerous regulatory cases, including warning letters, seizures, and corporate-wide injunctions.
Kristen Grumet Skills
Kristen Grumet Education Details
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University Of Colorado At BoulderBiology, General
Frequently Asked Questions about Kristen Grumet
What company does Kristen Grumet work for?
Kristen Grumet works for Greenleaf Health Inc.
What is Kristen Grumet's role at the current company?
Kristen Grumet's current role is Senior Vice President, Regulatory Compliance.
What is Kristen Grumet's email address?
Kristen Grumet's email address is kr****@****les.com
What is Kristen Grumet's direct phone number?
Kristen Grumet's direct phone number is (919)-998*****
What schools did Kristen Grumet attend?
Kristen Grumet attended University Of Colorado At Boulder.
What skills is Kristen Grumet known for?
Kristen Grumet has skills like Fda, Quality System, Medical Devices, Quality Assurance, Regulatory Affairs, Quality Auditing, Validation, Capa, Quality Control, Design Control, Gmp, Iso 13485.
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