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Senior Quality Assurance & Regulatory Consultant

Eingestellt von Berry Technical

Gesuchte Skills: Consultant, Support

Projektbeschreibung

Senior Quality Assurance & Regulatory Consultant
CHF Negotiable
Solothurn, Switzerland
6 month contract

Our client is seeking a Legacy Review professional to join their team on site in Switzerland, main duties will include Performing remediation activities generated from the Management Review Legacy Reviews to ensure adequate product and process risk review.

MAIN DUTIES & RESPONSIBILITIES:

* Perform Management Review remediation per schedule.
* Access product and process risk and alert management of product quality & compliance issues for proper and timely escalation to CAPA.
* Engage with local Quality Management and site process SMEs to ensure adequate actions are taken.
* Provide support for documentation of remediation activities.
* TO ADHERE TO THE COMPANY'S PROCEDURES AS DETAILED IN THE SOP MANUAL

KEY COMPETENCIES REQUIRED:

* Strong collaboration and influencing skills to partner effectively with various functions and across Operating Units - Both Internally and Externally
* Expert knowledge of the US Quality System Regulations and ISO 13485
* Demonstrated track record of delivering best in class results in the Quality Systems area
* The ability to independently execute risk assessments and remediation activities
* Fluent in German and in English - able to review CAPA & sub-system data and documents & interact with Quality Management & site process SMEs

QUALIFICATIONS & EXPERIENCE

ESSENTIAL:

* Strong knowledge of quality and compliance for Medical Device Industry (GMPs).
* Working knowledge of Quality System Regulations.
* A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement
* Experience in FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards
* Demonstrated knowledge of business impact of compliance issues and risk management
* Proven ability to build partnerships both internally and externally

Projektdetails

  • Einsatzort:

    Solothurn, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Berry Technical