Senior QA Consultant

4/2014 – 12/2014

Constar GmbH - Consultative services since April 2014
Consulting quality management topics, optimization of the QM Systems and processes according to ISO 13485, ISO 9001, DIN EN ISO 14971, 21CFR Part 820 and 21CFR Part 11, GMP
- Quality Control
- Quality Assurance
- Corrective and Preventive Action (CAPA)
- Nonconformity, Deviation, Complaint
- Risk Management, FMEA
- Change Control
- Documentation Control
- Training
- Auditing

Roles and responsibilities
• Management Office Northwest Switzerland
• Project Management of client projects
• Recruiting and on-boarding of QA consultants
• Coordinate training and qualification of junior QA consultants
• Supervising and monitoring performance of staff

Technisches Qualitätsmanagement / QS / QA, Change Management, Management (allg.), Prozessberatung, Qualitätsmanagement (allg.), Risikomanagement, Schulung / Coaching (allg.), Compliance management

6/2013 – 3/2014

• EMEA CAPA Manager of 13 Synthes manufacturing sites, leading one direct report
• EMEA CAPA process leader and representative in internal and external audits/inspections
• Lead EMEA CAPA review board (CRB)
• Review and approval of CAPAs as CRB member
• Member of EMEA Management Review
• Project Leader for the Global CAPA Legacy Review and Remediation Project
• Recruiting, on-boarding and supervising a team of 35 external CAPA consultants
• Lead a team of external CAPA consultants to support Europe-wide implementation of processes and systems to deliver consistent CAPAs compliant with company standards and Medical Device Regulations
• Coordinate daily huddles and ensure performance measurement of CAPA consultants
• Coordinate a team of CAPA trainers to deliver education and workshops to CAPA users
• Establish CAPA Train the Trainer concept and training effectiveness verification to ensure CAPA users are compliant with Synthes CAPA Content Standard (incl. Problem Statement, Risk assessment, Containment and Correction, Failure Investigation, Corrective and Preventive Action planning and implementation of actions including Effectiveness)
• Europe-wide roll-out of CAPA Review Boards (CRB)
• Europe-wide roll-out of CAPA KPIs/metrics including timeliness monitoring
• Deliver EMEA CAPA metrics to Management Review

Qualitätsmanagement / QS / QA (IT), Change Management, Projektmanagement, Qualitätsmanagement (allg.), Risikomanagement, Schulung / Coaching (allg.), Compliance management

2/2010 – 5/2013

• Corporate CAPA Manager at Institute Straumann AG
• Ensure CAPA process execution, accountability and due diligence while interfacing closely with key members of management
• Drive improvements in product and process performance
• Corporate CAPA process representative in all internal and external audits/inspections
• Project Leader for design and development of web based Quality Management System (CAPA / NCR / Complaints / Audit observations management)
• Responsible for roll-out of Global Exception Management System and standardizing Straumann CAPA Management process across all sites
• Establishment of the Train-the-Trainer concept
• Responsible for developing and implementing measures to monitor the effectiveness of the CAPA process
• KPI reporting on a regular basis and supplying the status of CAPA/NCR metrics to Corporate Management Review process
• Lead MRB (Material Review Board) and CRB (CAPA Review Board) meetings

Special achievements
• Successful implementation of web-based QMS and elimination of CAPA backlog
• Successfully presented CAPA process during internal and external inspections
• Demonstrated leadership ability, excellent communication and training skills

Qualitätsmanagement / QS / QA (IT), Schulung / Training (IT), Rollout, Konzeption (IT), Technisches Qualitätsmanagement / QS / QA, Projektmanagement, Qualitätsmanagement (allg.), Risikomanagement, Schulung / Coaching (allg.), Compliance management