ProClinical is working with a global medical device company who is seeking a QA Manager to be based in Frankfurt, Germany, on a contract basis. The QA Manager will be the Management Representative at the clients Frankfurt Office, tracking / trending / reporting Key Quality Performance Metrics and providing continuous Improvement of the Quality Management System, to assure alignment with ISO 13485, Medical Device Directive, corporate and other applicable quality environments.
- Ensures the QMS is effectively established and maintained to meet expected internal / external requirements, as part of a risk-based, critical thinking, decision making process
- Manages all QMS audits; investigates & provides guidance & support to address non-compliances from both internal and external inspections
- Performs investigations / root cause analysis and initiates CAPAs
- Reviews / approves product complaints; manages appropriate correspondence with customers regarding product complaints; prepares / submits Vigilance Reports to applicable Health Authorities as required
- Assigned as the Safety Officer under German Law
- Reviews / modifies / maintains internal operating policies related to the QMS, SOPs and Work Instruction s
- Responsible for maintaining the internal Document Control System
- Reviews / prepares / presents the QMS metrics & goals to the leadership team, as part of the annual Management Review
- Manages the documentation to obtain Free Sales Certificates for new and renewed product registrations, as per Marketing request
- With HR, provides comprehensive Quality System Training to those employees
- Effectively manages the activities and development of direct reports; resources and budgets; necessary to perform the functions of the QA Department
- Ensures achievements of assigned MBOs and business milestones
- Represents Client on quality assurance topics during interactions with Health Authorities and Notified Bodies.
Skills and Requirements:
- Bachelor's Degree in a scientific field (Chemistry, Biology, Pharmaceuticals, Engineering), Master's preferred
- Minimum of 5-7 years of experience in the Medical Device industry
- Minimum of managing direct reports for 2-3 years
- Verbal and written proficiency in English and German
- Familiar with current requirements of ISO 13485 and ISO 14971
- Experience with product vigilance reporting
- Able to manage different personalities in an international field, good interpersonal communications
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nick Dietz on +44 203 3193 033 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.