David Derrick

David Derrick Email and Phone Number

Director, Quality and Regulatory Affairs @ Galt Medical
Rowlett, TX, US
David Derrick's Location
Rowlett, Texas, United States, United States
David Derrick's Contact Details

David Derrick work email

David Derrick personal email

n/a
About David Derrick

Results oriented quality assurance & regulatory affairs professional with over eighteen years in medical device industry. Experience developing, implementing, and sustaining quality systems to ensure compliance with 21 CFR Part 820, 211, 11 and EU directives MDD 93/42/EEC, CMDR, Japan’s PAL, Australian TGA, as well as ISO 13485, ISO 9001, ISO 14971, IEC60601. Well-developed communication skills necessary for creating and performing facility wide training, communicating with customers/clients/regulatory bodies, managing external and internal audits, and resolving issues with regulatory bodies. Highly proficient in the development of regulatory strategies, implementation of plans with all levels of management, and across multi-functional disciplines. Capable of effectively maneuvering in large scale medical device companies and smaller companies with an entrepreneurial culture.

David Derrick's Current Company Details
Galt Medical

Galt Medical

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Director, Quality and Regulatory Affairs
Rowlett, TX, US
Website:
galtneedletech.com
Employees:
58
David Derrick Work Experience Details
  • Galt Medical
    Director, Quality And Regulatory Affairs
    Galt Medical
    Rowlett, Tx, Us
    View
  • Galt Medical
    Director, Quality & Regulatory Affairs
    Galt Medical Sep 2011 - Present
    Garland, Texas, Us
    Responsibilities include directing all quality and regulatory functions at the Garland, TX facility. Principle focus on developing, and implementing long and short-term strategic goals to ensure Galt Medical’s evolution from a small entrepreneur company to an innovative leader in the interventional radiology/cardiology and vascular surgery markets. Establish site quality/regulatory requirements and coordinate all FDA/EU/Canadian activities including license renewals, inspections, regulatory submissions (510k, EU, TGA, Latin America), and product registrations.
    View
  • Showa Best Inc.
    Corporate Ra/Qa Manager (Multi-Site Management Representative)
    Showa Best Inc. 2010 - 2011
    Responsibilities include directing all quality and regulatory functions at two US locations, Menlo, GA & Fayette, AL, and two Guatemala locations, Puerto Barrios & Guatemala City with the focus of establishing world-leading design and manufacturing operations at all locations.
  • Angiodynamics, Inc
    Qa/Ra Manager (Multi-Site Management Representative)
    Angiodynamics, Inc 2006 - 2010
    Responsibilities include directing all quality and regulatory functions at two locations; Manchester, Ga and Fremont, CA Managed the implementation of long and short-term strategies goals, objectives as outlined by the corporate management team.
  • Mentor, Inc
    Qa Manager
    Mentor, Inc 2000 - 2006
    Responsibilities include managing three QA laboratories, assigning tasks to 18 technicians, conducting supplier audits, evaluating supplier performance and served as quality representative on multiple R&D and engineering product development projects.

David Derrick Skills

Iso 13485 Medical Devices Quality System Quality Assurance Fda Iso Capa Regulatory Affairs Gmp Design Control Cross Functional Team Leadership Validation Iso 14971 Project Management Lean Manufacturing R&d Quality Management Root Cause Analysis 21 Cfr Part 11 Continuous Improvement Regulatory Submissions Quality Auditing Biomedical Engineering Change Control Design Of Experiments Quality Systems Quality Engineering V&v Spc Supplier Quality Fda Gmp Ce Marking Corrective And Preventive Action Iso Standards Quality Control U.s. Food And Drug Administration

David Derrick Education Details

  • North Carolina State University
    North Carolina State University
    Electronics Engineering
  • Central Carolina
    Central Carolina
    Electronics Engineering

Frequently Asked Questions about David Derrick

What company does David Derrick work for?

David Derrick works for Galt Medical

What is David Derrick's role at the current company?

David Derrick's current role is Director, Quality and Regulatory Affairs.

What is David Derrick's email address?

David Derrick's email address is dd****@****cal.com

What schools did David Derrick attend?

David Derrick attended North Carolina State University, Central Carolina.

What skills is David Derrick known for?

David Derrick has skills like Iso 13485, Medical Devices, Quality System, Quality Assurance, Fda, Iso, Capa, Regulatory Affairs, Gmp, Design Control, Cross Functional Team Leadership, Validation.

Who are David Derrick's colleagues?

David Derrick's colleagues are Carroll Gray, Qcmolding Qcmolding, Quita Singletary, Eva Smith, Varghese Francis, James Greenwood, Julia King.

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