Medical Devices, Project Management, QA, CAPA

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

Ich biete

Technik, Ingenieurwesen
  • Technisches Projektmanagement
  • Technische Projektleitung / Teamleitung

Projekt‐ & Berufserfahrung

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

1/2017 – 7/2017


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
Kundenname anonymisiert, Koln
1/2016 – 12/2016 (1 Jahr)
Medical Engineering

1/2016 – 12/2016


• 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

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

Project Manager
Kundenname anonymisiert, Copenhagen
8/2014 – 8/2015 (1 Jahr, 1 Monat)
Life Sciences

8/2014 – 8/2015


• 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
Kundenname anonymisiert, Copenhagen
8/2011 – 4/2012 (9 Monate)

8/2011 – 4/2012


• 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

Oracle Database, PeopleSoft (Oracle), Lohnbuchhaltung

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

8/2007 – 1/2011


• 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


Project Engineer
Kundenname anonymisiert, Bristol
10/2006 – 9/2007 (1 Jahr)
Luft- und Raumfahrtindustrie

10/2006 – 9/2007


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


Test Manager
Kundenname anonymisiert, Copenhagen
5/2002 – 9/2006 (4 Jahre, 5 Monate)

5/2002 – 9/2006


• 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
Kundenname anonymisiert, Louth
7/2000 – 7/2002 (2 Jahre, 1 Monat)
High-Tech- und Elektroindustrie

7/2000 – 7/2002


• 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
Kundenname anonymisiert, Louth
12/1998 – 7/2000 (1 Jahr, 8 Monate)
High-Tech- und Elektroindustrie

12/1998 – 7/2000


• 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

Testmanagement / Testkoordination (IT)

Medical Engineer
Kundenname anonymisiert, Dublin
7/1994 – 5/1995 (11 Monate)
Maschinen-, Geräte- und Komponentenbau

7/1994 – 5/1995


• 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



International Association for the Advancement of Space Safety
November 2012

Diploma in Leadership
August 2010


Master of Management
Jahr: 2014
Ort: Copenhagen

Bachelor of Engineering in Product Design Engineering. B.Eng
Jahr: 1998
Ort: Dundalk

National Diploma in Engineering
Jahr: 1996
Ort: Dundalk

National Certificate in Engineering
Jahr: 1994
Ort: Dundalk


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

Über mich

• IT: Agile, TrackWise, SAP, Oracle, PSPICE, Matlab, LabVIEW, C++, QlikView, SharePoint, Linux, Microsoft, OSX
• Languages: English – Native. Danish, German, French – Some knowledge
• Driver’s License
• Publication: Vulnerability and Capacity Assessment: Dhaka- Bangladesh. (Co-author)
• Elected professional member of the International Association for the Advancement of Space Safety, IAASS
• Thesis subject was patient safety in the trauma centre of a major city hospital
• Attended American Association for Healthcare Engineering, ASHE, in 2012

Persönliche Daten

  • Englisch (Muttersprache)
  • Deutsch (Grundkenntnisse)
  • Französisch (Grundkenntnisse)
  • Dänisch (Fließend)
auf Anfrage
  • Europäische Union
22 Jahre (seit 07/1998)
15 Jahre


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