Quality Engineer

Business Unit: GE HealthcareFunction: QualityResponsibilities: The successful candidate in the Quality Engineering role will have direct daily interaction with LSS cross-functional teams in local (Madison) and global projects, advising and ensuring compliance with local and global product and process quality requirements.He/she will:Participate in the development of product specificationsContribute to NPI projects in test & validation requirements, regulatory requirements, spec development, hazard and safety analyses and other quality activitiesAssist in the preparation of process validation plans and product verification acceptance plansParticipate in supplier selection and qualification activitiesPrepare or participate in validation of engineering changes where requiredReview major engineering changes for safety and potential regulatory clearance issuesSupport complaint investigationsParticipate in design reviews, ensuring conformance with design controls procedures and regulationsReview labeling, promotional materials and technical communications, written and electronic, for commercial and investigational productsParticipate in training for new QA team members and new/all LSS employees, as requiredEmploy appropriate statistical analysis methodologies for quality data analysis and prepare appropriate reports for PPTs, functional groups and LSS managementRecommend, perform CAPA when data, issues point out the needReview and approve quality system deviations, when appropriateReview and approve scientific and technical documents intended for submission, ensuring the data meets quality/regulatory requirementsManage assigned projects in conjunction with project teams in a complex, highly-matrixed environmentDevelop and review departmental and corporate policies and procedures within areas of expertiseParticipate in regulatory agency audits and inspectionsPerform internal and external audits~HJ~
REQUIREMENTS
Qualifications: *Bachelor's degree in Engineering or Physical Science (or AAS degree and 8+ years work experience in the Quality Assurance field, preferably in the medical device industry)
5+ years work experience in the Quality Assurance, engineering, scientific or biomedical discipline, preferably in the medical device industry
Understanding of Quality System requirements - QSR, MDD, others
Experience with practical application of fundamental quality problem-solving and improvement concepts, methodologies and tools
Ability to read, analyze and interpret technical documentation, standards and regulations
Strong working knowledge of FDA, European and Global regulations
Excellent oral and written communication skills
You must have unrestricted authorization to work in the United States.
You must be willing to take a drug test as part of the selection process.
You must be willing to submit to a background investigation as part of the selection process.
You must submit your application for employment through Gecareers.com to be considered.
To the extent you are applying for a position that requires you to operate a GE owned/leased, privately owned/leased or rental vehicle for company business, you must be willing to submit to a check of your driving record.Desired: * MS degree in physical science
Professional clinical education/experience
Design engineering/V&V background, experience
Able to command peer respect as a result of a combination of educational background and work-related experience
Strong inter-personal skills - Ability to work effectively in a team environment
Computer literate with experience with general office and telecommunication software programs
Team player with a global mindset
Capable of multi-tasking and handling tasks with competing priorities effectively
Basic understanding of LSS clinical applications
Quality system audit experience
Six Sigma Certification
CQE, CQA, RAC, Lead Auditor certificationGeneral: GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation.The United States has regulations that govern the hiring of current or former U.S. Government employees. If you currently work for (or have in the past) the U.S. Government (in any capacity), you may have certain responsibilities under these regulations and certain restrictions may apply to your potential employment with GE. Therefore, if you are contacted by GE regarding a position of employment, and you have worked for the U.S. Government at any time, please immediately inform the GE representative of this fact.