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Quality Assurance Leader (m/f)

  • GE Healthcare
  • Experienced
  • Posted 5/8/2017 3:17:57 PM
  • 2895052
  • Job Function: Quality
  • Business Segment: Healthcare Quality
Location(s): Switzerland; Eysins


About Us:
There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can.

Role Summary:
The QA Leader will manage quality systems, processes and procedures to assure product safety and quality by driving business alignment to correct industry requirements and business objectives by managing quality system design, controls, and continuous improvement on site at Biosafe, Eysins. Responsibility includes global QA support of the business within the growing Cell Therapy business.

Essential Responsibilities:
• Accountable for assisting the Quality Assurance Site Manager to ensure/ follow up/ implement corrective actions that are raised by deviations, internal audit or regulatory inspection 
• Supporting the site QA leader in GEHC QMS integration, in implementing the GEHC Quality Management System (QMS), and in maintaining the existing certifications
• Responsible for managing quality systems, processes and procedures to assure product quality and safety
• 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
• Influencing site compliance to Quality policy, QMS procedures, and implemented standards e.g. ISO13485
• Influencing participation in compliance to internal and external regulations
• Influencing quality system metrics such as Corrective and Preventive Action, training metrics, and complaint resolution metrics

Qualifications/Requirements:
• Bachelor’s degree (or high school diploma)
• Several years of experience working in a preferably regulated medical device environment, quality control/ assurance, or regulatory assurance
• Ability to effectively communicate using English and French language
• Demonstrated experience in the medical device or pharmaceutical industry and knowledge of quality system regulations and policies
• Demonstrated ability to develop & lead process implementation & improvement in a team environment
• Experience with some or all of the following:
• Design controls, design verification and validation activities
• Production and process controls
• CAPA, complaints and risk management
• Experience performing internal audits

Desired Characteristics:
• Demonstrated effective interpersonal and networking
• Prior experience using word processing, spreadsheet, and presentation software
• Effective oral and written communication skills
• Analytical & problem-solving skills/ root-cause analysis
• Conflict-resolution skills
• Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner
• Ability to prioritize and drive multiple programs
• Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
• Accepting constructive criticism and dealing calmly and effectively with high-stress situations

Locations: Switzerland; Eysins
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