freiberufler Medical Devices, QMS, Risk Management, Usability, CAPA, PMS, ISO13485, ISO14971 auf freelance.de

Medical Devices, QMS, Risk Management, Usability, CAPA, PMS, ISO13485, ISO14971

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  • 12.12.2024

Kurzvorstellung

Risk Management, Medical Device Regulation, Procedures, Technical Document, Regulatory, Engineering, Project Management, Quality Assurance, Safety, Product Development, CAPA.

Auszug Referenzen (2)

"Mit Carl habe ich zusammen gearbeitet in Gothenborg in die firma Molnlycke Health Care AB (HQ) - Schweden. Abteilung QA/ RA. Carl ist ein profi RA."
QA Manager Consultant (FDA Readiness Projects)
Lans
Tätigkeitszeitraum

1/2017 – 7/2017

Tätigkeitsbeschreibung

FDA Readiness.
Gap analysis.
QSR, CAPA, Complaints, Design Control, SAfety Assessments
Resource planning and costing
Remediation work
Risk assessments

Eingesetzte Qualifikationen

Technisches Qualitätsmanagement / QS / QA

"I can strongly recommend B. as a highly competent and pleasant colleague with significant skills in all aspects of Quality Management."
Project Manager
Helmut Trautmann
Tätigkeitszeitraum

8/2014 – 8/2015

Tätigkeitsbeschreibung

• CAPA process owner for an FDA remediation program reporting to Director of Quality
• Spearheaded CAPA teams to resolve issues and cases e.g. shipping of non-compliant products
• Directed, managed and coached the CAPA team, set up and chaired the CAPA Board whose purpose was to perform assessments and determine which cases merited CAPA investigation
• Developed the CAPA and NCR processes and procedures, provided CAPA training
• Harmonized procedures across US and European sites
• Provide support for manufacturing operations e.g. SOP’s deviations, waivers and performed change control
• Perform general Quality activities for reagents, packaging, plastics, components and parts
• Secure compliance to regulations (ISO13485 / 21CFR). Follow up FDA inspection Jan 2015 was passed. FDA close out letter (April 2015) lists all identified issues as resolved.

Eingesetzte Qualifikationen

Technisches Qualitätsmanagement / QS / QA

Qualifikationen

  • Beng
  • Qualitätsmanagement (allg.)5 J.
  • Risikomanagement
  • Technisches Projektmanagement
  • Technisches Qualitätsmanagement / QS / QA6 J.

Projekt‐ & Berufserfahrung

Senior Quality Manager
Barco, Kortrijk
3/2024 – 7/2024 (5 Monate)
Life Sciences
Tätigkeitszeitraum

3/2024 – 7/2024

Tätigkeitsbeschreibung

Quality assurance and regulatory support of medical device development projects
CAPA handling, Complaints, Risk Management, Design Transfer

Eingesetzte Qualifikationen

Qualitätsmanagement (allg.)

Risk Engineer
Le Maitre, Remote
8/2020 – 12/2020 (5 Monate)
Life Sciences
Tätigkeitszeitraum

8/2020 – 12/2020

Tätigkeitsbeschreibung

Performed risk management assessment and updates for vascular graft products

Eingesetzte Qualifikationen

Risikomanagement

Senior QA Engineer
Johnson&Johnson, Groningen
1/2020 – 6/2023 (3 Jahre, 6 Monate)
Life Sciences
Tätigkeitszeitraum

1/2020 – 6/2023

Tätigkeitsbeschreibung

Risk Management, Design Control and QA activities of New Product Development

Eingesetzte Qualifikationen

Technisches Qualitätsmanagement / QS / QA

Senior Quality Assurance Consultant
GN Hearing, Kopenhagen
12/2019 – 9/2024 (4 Jahre, 10 Monate)
Life Sciences
Tätigkeitszeitraum

12/2019 – 9/2024

Tätigkeitsbeschreibung

QA, compliance, regulatory activities during new product development.
Regulatory assessments, 510K submissions, compiling the technical file.
Risk Management, Usability Engineering
Complaints, non-conformances, PSUR, Trending
Audit management

Eingesetzte Qualifikationen

Qualitätsmanagement (allg.), Qualitätsrichtlinien, Qualitätssicherungssysteme

QA Specialist
GE Healthcare, Kopenhagen
7/2019 – 8/2020 (1 Jahr, 2 Monate)
Life Sciences
Tätigkeitszeitraum

7/2019 – 8/2020

Tätigkeitsbeschreibung

Correct the Risk Management Process and CAPA Process for an MDSAP Audit

Eingesetzte Qualifikationen

Technisches Qualitätsmanagement / QS / QA

QA Specialist
Natus Medical, Kopenhagen
8/2018 – 7/2019 (1 Jahr)
Life Sciences
Tätigkeitszeitraum

8/2018 – 7/2019

Tätigkeitsbeschreibung

Correct the Risk Management Process and CAPA Process for an MDSAP Audit.

Eingesetzte Qualifikationen

Technisches Qualitätsmanagement / QS / QA

QA Manager Consultant (FDA Readiness Projects)
Molnlycke, Gothenburg
1/2017 – 7/2017 (7 Monate)
Life Sciences
Tätigkeitszeitraum

1/2017 – 7/2017

Tätigkeitsbeschreibung

FDA Readiness.
Gap analysis.
QSR, CAPA, Complaints, Design Control, SAfety Assessments
Resource planning and costing
Remediation work
Risk assessments

Eingesetzte Qualifikationen

Technisches Qualitätsmanagement / QS / QA

Project Manager
Varian Proton Therapy, Koln
1/2016 – 12/2016 (1 Jahr)
Medical Engineering
Tätigkeitszeitraum

1/2016 – 12/2016

Tätigkeitsbeschreibung

• Project Management of nuclear medical engineering; development projects and installation activities
• Coordinated between engineering, field service, installation and commissioning teams to resolve issues for “first-of-a-kind” complex nuclear medical systems.
• Leading cross-functional teams to deliver new and upgraded products within a strongly regulated device environment.

Eingesetzte Qualifikationen

Qualitätsmanagement (allg.), Projektmanagement - Projekt-Training, Vermessung, Anlagentechnik, Installation / Montage / Wartung (allg.)

Project Manager
Agilent Technologies, Copenhagen
8/2014 – 8/2015 (1 Jahr, 1 Monat)
Life Sciences
Tätigkeitszeitraum

8/2014 – 8/2015

Tätigkeitsbeschreibung

• CAPA process owner for an FDA remediation program reporting to Director of Quality
• Spearheaded CAPA teams to resolve issues and cases e.g. shipping of non-compliant products
• Directed, managed and coached the CAPA team, set up and chaired the CAPA Board whose purpose was to perform assessments and determine which cases merited CAPA investigation
• Developed the CAPA and NCR processes and procedures, provided CAPA training
• Harmonized procedures across US and European sites
• Provide support for manufacturing operations e.g. SOP’s deviations, waivers and performed change control
• Perform general Quality activities for reagents, packaging, plastics, components and parts
• Secure compliance to regulations (ISO13485 / 21CFR). Follow up FDA inspection Jan 2015 was passed. FDA close out letter (April 2015) lists all identified issues as resolved.

Eingesetzte Qualifikationen

Technisches Qualitätsmanagement / QS / QA

International Associate
United Nations Development Programme, Copenhagen
8/2011 – 4/2012 (9 Monate)
International
Tätigkeitszeitraum

8/2011 – 4/2012

Tätigkeitsbeschreibung

• Liaised with HR, finance, treasury and field offices to resolve complex payroll-related issues
• Investigate technical errors in the payroll system (Oracle)
• Utilized information system tools to increase efficiency
• Ensure compliance to UN policies and standard regulations
• Reengineered processes and improved system implementations

Eingesetzte Qualifikationen

Lohnbuchhaltung, Oracle Database, People Soft

Task Force Manager
Nokia, Ulm & Copenhagen
8/2007 – 1/2011 (3 Jahre, 6 Monate)
High-Tech- und Elektroindustrie
Tätigkeitszeitraum

8/2007 – 1/2011

Tätigkeitsbeschreibung

• Led large-scale dynamic teams, managing multiple complex issues, in project mode within a virtual environment
• Led top quality issues management and resolution
• Performed analysis and resolution of cases associated with design verification and qualification
• Designed for manufacture, service and drove the reduction of failure rates and warranty costs
• Significantly reduced component failure rates and testing costs in production
• Quality-managed multiple in-market products from launch to ramp down.
• Risk managed all engineering changes

Eingesetzte Qualifikationen

Projektmanagement

Project Engineer
Airbus Military, Bristol
10/2006 – 9/2007 (1 Jahr)
Luft- und Raumfahrtindustrie
Tätigkeitszeitraum

10/2006 – 9/2007

Tätigkeitsbeschreibung

As a Project Manager on A400M (Manufacturing – Electrical Test), I performed the following duties:
• Performed Failure Modes and Effects Analysis (FMEA), Material Analysis, Electromechanical Analysis
• Developed system to test lightning protection of the wing at all aircraft stages
• Performed planning and scheduling of manufacturing test processes to be transferred
• Applied design info. to the electrical bonding project for all wing systems, at all build stages
• Applied regulatory requirements to all aspects of manufacture and test for lightning protection

Eingesetzte Qualifikationen

Projektdurchführung

Test Manager
GN NETCOM, Copenhagen
5/2002 – 9/2006 (4 Jahre, 5 Monate)
Telekommunikation
Tätigkeitszeitraum

5/2002 – 9/2006

Tätigkeitsbeschreibung

• Responsible for all product validation, test and verification activities
• Assured product reliability; performed electrical environmental and mechanical testing
• Analysed product failures and composed investigation reports during qualification testing
• Performed CAPA case assessments and processing
• Devised design verification test procedures to comply with ISO, CE and UL regulations
• Set-up and headed an international product validation group
• Directed test activity and achieved project targets for multiple products, from womb to tomb

Eingesetzte Qualifikationen

Advanced product quality planning (APQP)

Product Engineer
Maxtor Corp, Dublin
7/2000 – 7/2002 (2 Jahre, 1 Monat)
High-Tech- und Elektroindustrie
Tätigkeitszeitraum

7/2000 – 7/2002

Tätigkeitsbeschreibung

• Performed design-verification and qualification testing for all new products
• Performed drive level failure analysis (reliability analysis; electronic, mechanical, chemical, firmware)
• Utilized a CAPA process for QA activities i.e. analysis of CAPA cases according to sampling plans

Eingesetzte Qualifikationen

FMEA (Failure Mode and Effects Analysis)

Failure Analysis Engineer
Quantum Corp, Dublin
12/1998 – 7/2000 (1 Jahr, 8 Monate)
High-Tech- und Elektroindustrie
Tätigkeitszeitraum

12/1998 – 7/2000

Tätigkeitsbeschreibung

• Established an in-house failure analysis lab and devised associated operational procedures
• Determined methods and procedures for prototype and high volume production testing
• Developed product test standards and test schedules

Eingesetzte Qualifikationen

Test Management

Medical Engineer
Siemens, Dublin
7/1993 – 5/1995 (1 Jahr, 11 Monate)
Maschinen-, Geräte- und Komponentenbau
Tätigkeitszeitraum

7/1993 – 5/1995

Tätigkeitsbeschreibung

• Performed quality assurance for life support systems (artificial respi¬ra¬tion and critical patient systems)
• Installed, maintained and supported electro medical life-support systems at hospital facilities nationwide
• Commissioned and installed X-Ray, CT and MRI systems with international specialist teams
• Performance monitored and planned prevention maintenance for life support systems (E-Medical and Nuclear)
• Provided emergency on-site support, training and advice to professional hospital staff nationwide

Eingesetzte Qualifikationen

Elektrotechnik

Zertifikate

International Association for the Advancement of Space Safety
2012
Diploma in Leadership
2010

Ausbildung

Master of Management
Ausbildung
2014
Copenhagen
Bachelor of Engineering in Product Design Engineering. B.Eng
Ausbildung
1998
Dundalk
National Diploma in Engineering
Ausbildung
1996
Dundalk
National Certificate in Engineering
Ausbildung
1994
Dundalk

Über mich

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Weitere Kenntnisse

Master of Management University of Copenhagen, Denmark
Bachelor of Engineering, with Honours Dundalk Institute of Technology, Ireland
National Diploma in Engineering, with Distinction Dundalk Institute of Technology, Ireland
National Certificate in Engineering Dundalk Institute of Technology, Ireland

Persönliche Daten

Sprache
  • Englisch (Muttersprache)
  • Dänisch (Fließend)
  • Deutsch (Grundkenntnisse)
  • Französisch (Grundkenntnisse)
Reisebereitschaft
Europa
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Profilaufrufe
2824
Berufserfahrung
26 Jahre und 5 Monate (seit 07/1998)
Projektleitung
15 Jahre

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