The Safety Standards Technical Leader oversees the day-to-day operation of the local internal Safety Laboratory within GE HealthCare and provides training and guidance to the Safety Technicians and Safety Engineers relative to performing safety standards compliance testing internal of customer products. The Safety Laboratory primarily tests medical devices per the requirements of the IEC 60601 series and other relevant standards for multiple sub-business of GE HealthCare
Key ResponsibilitiesAssure the quality of Safety Laboratory testing per the requirements of the appropriate regulating standards
Understand laboratory operations and personnel competency requirements as required under the GE HealthCare Quality System, ISO/IEC 17025 quality system requirement for test laboratories and IEC 60601 series and other relevant safety standards
Maintain laboratory accreditations with A2LA and Intertek and interface with internal and external auditors
Review and approve all safety test plans and reports;
Create and revise construction and test reports for Intertek
Stay current on relevant Standards and assess laboratory impacts of changes
Oversee safety Laboratory day-to-day operations
Interface with internal customers and external testing laboratories (i.e. Intertek) in arranging and conducting testing
Clarify internal customer’s facility and test needs to assure laboratory meets internal customer’s and external testing laboratory's requirements
Provide guidance to internal customers regarding safety standard requirements
Define test input requirements and work with internal customers and eesting laboratoryin completing appropriate test plans
Manage safety test schedules and assign responsible test personnel
Oversee and direct laboratory personnel work tasks
Assist Global Laboratory Manager with creation of yearly budget and test equipment needs
Provide training of Safety Technicians and Safety Specialists to ensure competency level of individuals performing safety tests are appropriate per the relevant standards and procedures
Prvide safety standars onsite testing support for regulatory bodies such as KFDA (Korea) and NMPA (China)
Be aware of and comply with the GEHC Quality Manual, Quality Management System including Safety Lab specific Quality System Regulations (QSR), Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Complete all planned Quality and Compliance training within the defined deadlines
Identify and report any Quality or Compliance concerns and take immediate corrective action as required
Keep up-to-date on knowledge and understanding of current regulatory requirements within area of responsibility to ensure laboratory accreditations are maintained
Effectively support implementation, training and management of current regulatory requirements in safety testing
Maintain Satety Laboratory accreditations
Education requires a Bachelor of Science Degree or equivalent
Experience working for/with safety testing laboratories such as Intertek, UL, CSA, TUV SGS, etc
Working knowledge of tasks needed to maintain safety laboratory accreditations
Working knowledge of the major sections of the ISO/IEC 17025
Experience with the operation and effectiveness of a Quality Management System within a laboratory and experience with measuring staff competence
Experience operating an accredited safety laboratory
Personal presentation requirements are: proven organizational kills, Excellent written and verbal communication skills and a strong sense of team work
Consultative selling experience is also to be considered
Master of Science or equivalent optional
Experience in applying/interpreting/testing IEC 60601-series standards for medical devices
Knowledge of Quality Management Systems for the medical device industry
Leadership skills; experience providing direction to lower-level or more junior employee
Strong working knowledge of Microsoft Word, Excel and Power Point
Strong analytical and problem-solving skills
Ability to interpret technical writing documents (i.e. Engineering and Manufacturing)
Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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