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Gordon Smith Email & Phone Number

Senior Quality Assurance Specialist I at Miltenyi Biotec
Location: Rocklin, California, United States 6 work roles 1 school
1 work email found @norcalcontrols.net LinkedIn matched
✓ Verified May 2026 4 data sources Profile completeness 100%

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Work email g****@norcalcontrols.net
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Current company
Miltenyi Biotec
Role
Senior Quality Assurance Specialist I
Location
Rocklin, California, United States

Who is Gordon Smith? Overview

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Quick answer

Gordon Smith is listed as Senior Quality Assurance Specialist I at Miltenyi Biotec, based in Rocklin, California, United States. AeroLeads shows a work email signal at norcalcontrols.net and a matched LinkedIn profile for Gordon Smith.

Gordon Smith previously worked as Quality Manager at Nor-Cal Controls Es, Inc. and Quality Manager at Medtronic. Gordon Smith holds Quality Assurance from De Anza College.

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Email format at Miltenyi Biotec

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{first}.{last}@norcalcontrols.net
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AeroLeads found 1 current-domain work email signal for Gordon Smith. Compare company email patterns before reaching out.

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Profile bio

About Gordon Smith

Analytical and collaborative business partner with experience in design, process development, and manufacturing of medical devices. Seasoned background in implementation of Quality Management Systems, ISO 13485 and ISO 9001. Adept at facilitating internal and third-party audits, risk management, corrective and preventive action, inspection readiness, process development and improvement strategies - leading to reduced audit findings and strengthened regulatory compliance. Versed in device FDA QMS regulations, CE marking, operations, supplier management, EtO and GAMMA sterilization, biocompatibility, packaging validation, inspection, and QMS development.My professional passion is to create Quality Management Systems that are scalable to any business and meet industry regulatory compliance.

Listed skills include Fda, Validation, Medical Devices, Compliance, and 25 others.

Current workplace

Gordon Smith's current company

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Miltenyi Biotec
Miltenyi Biotec
Senior Quality Assurance Specialist I
Website
miltenyibiotec.com
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6 roles · 26 years

Gordon Smith work experience

A career timeline built from the work history available for this profile.

Senior Quality Assurance Specialist I

Current
Miltenyi Biotec

Bergisch Gladbach, North Rhine-Westphalia, DE

Jul 2022 - Present

Quality Manager

Nor-Cal Controls Es, Inc.

El Dorado Hills, California, US

  • Ground up Quality Management System development, maintain Quality Policy, Objectives, Data Analysis, Regulatory, and Industry Standards. Collaborate with Engineering and Production teams to ensure company delivers.
  • Complaint Monitoring
  • Documented Information
  • Engineering QAQC Process
  • Measurement Traceability
  • Nonconformity and Corrective Action
Apr 2021 - Mar 2022

Quality Manager

Medtronic

Minneapolis, MN, US

  • Official Correspondent - Establishment and Device Registration, Regulatory responsibility. Managed personnel in Inspection, Engineering, and Logistics.
  • Completed Quality Management System upgrade to BS EN ISO 13485:2016.
  • Received 510(k) clearance for Biolox delta Femoral Head, K150576.
  • Completed biological evaluation plan through Nelson Labs for Hip and Knee Orthopedic Implant Systems in accordance with ISO 10993-1.
  • Monitor Change Management: New DCR, DHR, DMR/MDF, Routers, and DHF processes.
  • Created device labeling to include GS1 data matrix and harmonized symbols to ISO 15223.
Sep 2013 - Jan 2020

Director Of Quality

Zimmer Biomet

Warsaw, Indiana, US

  • Official Correspondent - Managed sterile device activities under ISO 7 class 10,000 CEA.Directed expansion division in Reno, NV; implemented FDA QSR, MDD/ISO 13485, and CMDR compliant systems.
  • Created validation procedures for GAMMA and EtO in accordance with ISO 11137-1 and 11135.
  • Managed sterile device packaging qualifications according to ISO 11607-1.
  • Received CE certification for Orthopaedic Prosthesis Implantation Instruments family of products.
2008 - 2013 ~5 yrs

Quality Manager

Nai Tech Products
  • Maintained US regulatory requirements. Led Document Control and streamlined ECN/DCN process. Managed second division in Camarillo, CA and achieved upgrade registration to ISO 13485.
  • Successfully passed FDA inspection with no observations or discussion, Aug. 2005.
  • Achieved the highest supplier rating given by GE-Healthcare for supplier QMS, March 2006.
  • Brought 2 divisions into compliance with Health Canada (CMDR) and European regulations (MDD).
2003 - 2008 ~5 yrs

Quality Control Manager

Dade Behring

Forchheim, DE

  • Oversaw QA/QC Department for IVDD instrument division. Managed software validation, inspection and test, MRB, CAPA, procedure development, and first article qualification.
  • Facilitated supplier management program; selection, audits, dock-to-stock, and continuous improvement.
  • Code Compliance Coordinator – Electrical Safety and EMC certification for “CE” mark.
2000 - 2003 ~3 yrs
Team & coworkers

Colleagues at Miltenyi Biotec

Other employees you can reach at miltenyibiotec.com. View company contacts →

AH Anna Hows Anna Hows Colleague at Miltenyi Biotec Greater Cambridge Area, United Kingdom View → CK Carolin Kolbe Carolin Kolbe Colleague at Miltenyi Biotec Bergisch Gladbach, North Rhine-Westphalia, Germany, Germany View → FN Fran Nederlof Fran Nederlof Colleague at Miltenyi Biotec Portland, Oregon, United States, United States View → SK Sophie Kummerlöwe Sophie Kummerlöwe Colleague at Miltenyi Biotec Cologne, North Rhine-Westphalia, Germany, Germany View → KJ Kent Jordan Kent Jordan Colleague at Miltenyi Biotec Auburn, California, United States, United States View → FK Fred Koller Fred Koller Colleague at Miltenyi Biotec San Diego, California, United States, United States View → KS Kaiserbert Süßman Kaiserbert Süßman Colleague at Miltenyi Biotec Cologne Bonn Region, Germany View → MP Matthias P. Matthias P. Colleague at Miltenyi Biotec Cologne, North Rhine-Westphalia, Germany, Germany View → HP Harm Pewe Harm Pewe Colleague at Miltenyi Biotec Teterow, Mecklenburg-West Pomerania, Germany, Germany View → BN Brandon Neigum Brandon Neigum Colleague at Miltenyi Biotec Byron, Minnesota, United States, United States View →
1 education record

Gordon Smith education

  • De Anza College
    De Anza College
    Quality Assurance
FAQ

Frequently asked questions about Gordon Smith

Quick answers generated from the profile data available on this page.

What company does Gordon Smith work for?

Gordon Smith works for Miltenyi Biotec.

What is Gordon Smith's role at Miltenyi Biotec?

Gordon Smith is listed as Senior Quality Assurance Specialist I at Miltenyi Biotec.

What is Gordon Smith's email address?

AeroLeads has found 1 work email signal at @norcalcontrols.net for Gordon Smith at Miltenyi Biotec.

Where is Gordon Smith based?

Gordon Smith is based in Rocklin, California, United States while working with Miltenyi Biotec.

What companies has Gordon Smith worked for?

Gordon Smith has worked for Miltenyi Biotec, Nor-Cal Controls Es, Inc., Medtronic, Zimmer Biomet, and Nai Tech Products.

Who are Gordon Smith's colleagues at Miltenyi Biotec?

Gordon Smith's colleagues at Miltenyi Biotec include Anna Hows, Carolin Kolbe, Fran Nederlof, Sophie Kummerlöwe, and Kent Jordan.

How can I contact Gordon Smith?

You can use AeroLeads to view verified contact signals for Gordon Smith at Miltenyi Biotec, including work email, phone, and LinkedIn data when available.

What schools did Gordon Smith attend?

Gordon Smith holds Quality Assurance from De Anza College.

What skills is Gordon Smith known for?

Gordon Smith is listed with skills including Fda, Validation, Medical Devices, Compliance, Regulatory Affairs, Quality Assurance, Qsr, and Capa.

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