Medical Devices, MDR, QMS, Risk Management, Usability, CAPA, PMS, ISO13485, ISO14971, IEC62366, IEC62304

12/2019 – 1/2025

Risk Management, Design Control, Technical File Submissions, MDR, FDA, CAPA, Post Market Surveillance, Usability. Technical Project Management

Qualitätsingenieur, Regulatory Affairs, Risikomanagement

12/2019 – 1/2025

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

Qualitätsmanagement (allg.), Qualitätsrichtlinien, Qualitätssicherungssysteme

7/2019 – 8/2020

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

Technisches Qualitätsmanagement / QS / QA

8/2018 – 7/2019

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

Technisches Qualitätsmanagement / QS / QA

1/2017 – 7/2017

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

Technisches Qualitätsmanagement / QS / QA

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.

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

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.

Technisches Qualitätsmanagement / QS / QA

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

Lohnbuchhaltung, Oracle Database, People Soft

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

Projektmanagement

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

Projektdurchführung

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

Advanced product quality planning (APQP)

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

FMEA (Failure Mode and Effects Analysis)

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

Test Management

7/1993 – 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

Elektrotechnik