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Quality Assurance Leader (m/f)

• GE Healthcare


• Experienced


• Posted 11/15/2018 8:55:18 AM


• 3208886

• Job Function:Quality


• Business Segment: Healthcare Life Sciences

Location(s): Switzerland; Eysins




Role Summary:

The QA Leader will manage quality systems, processes and procedures to assure product/ patient safety as well as quality by driving business alignment to correct industry requirements and business objectives. In addition to that, the QA Leader will manage quality system design, controls, and continuous improvement on site in our Cell Therapy business in Nyon (Eysins), CH together with the Quality Assurance Site Manager.




Essential Responsibilities:

• Accountable for assisting the Quality Assurance Site Manager to ensure/ follow up/ implement corrective actions that are raised by deviations, customer & internal audits or regulatory inspections


• Supporting the Quality Assurance Site Manager in maintaining and improving the Cell Therapy and site Quality Management System (QMS), and in maintaining the existing certifications (MDSAP, ISO13485:2016)


• Responsible for managing quality systems, processes and procedures to assure product quality and safety


• Owning Change control management on site in Nyon (Eysins)


• Reviewing and approving new products (NPI)


• Managing customer and internal audits on site in Nyon


• Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs)


• Owning the development and maintenance of policies and procedures for departmental functions


• Providing leadership and facilitates problem resolution


• Driving site compliance to Quality policy, QMS procedures, and implemented standards e.g. ISO13485, MDSAP


• Influencing participation in compliance to internal and external regulations


• Driving utilization of GEHC LS quality system metrics such as Corrective and Preventive Action (CAPA), training metrics, and complaint resolution metrics including input for trending and follow-up actions
  

Qualifications/Requirements:

• Bachelor’s degree in biology, biochemistry, chemistry or related.


• Five years of experience working in a preferably regulated medical device environment, quality control/ assurance, regulatory assurance or similar


• Ability to effectively communicate using English and French language


• Demonstrated ability to develop & lead process implementation & improvement in a team environment


• Demonstrated experience in a medical device or GMP industrial environment as well as knowledge of quality system regulations and policies


• Experience in managing customer & internal audits


• Experience in NCs and CAPA and Change Control management


• Experience with some or all the following: Design controls, design verification and validation activities, customer complaint management, Production and process controls, and risk management
  
  

About Us:

GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com



GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

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GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, and according with all local laws protecting different status.

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Locations: Switzerland; Eysins