GE HealthCare Safety Standards Technical Leader Laboratory 

United States, Wisconsin 

918741205

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 of internal 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.
Job Description

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 Responsibilities

• Assure 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)

Quality Specific Goals

• 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

Required Qualifications

• 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

Desired Qualifications

• 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.