Danaher Corporation Senior Quality Systems Specialist in Sunnyvale, California
ESSENTIAL JOB RESPONSIBILITIES:
Review records and documents, for completeness and compliance with QSR and ISO requirements.
Review batch record to support release of raw materials, work in progress and final products. This includes reagents, components and instrumentation-related products.
Collaborate with other function teams to resolve batch record discrepancies or errors as it related to Good Documentation Practice.
Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Report, as needed.
Lead and participate in interdepartmental initiatives for continuous improvement.
Provide guidance on general quality principles and procedural requirements.
Perform and complete work with a limited degree of supervision.
Solve problem in straightforward situations; analyze possible solutions using technical experience and judgment.
Represent Quality in cross-department meetings, as needed.
Acts as an internal resource to the specialists with less experience. Provide on-job training and qualification exam to junior specialist.
Act like as a team lead, may allocate the work and provide the subject matter guidance to more junior specialists.
Support PDR closure, as needed.
Support Daily Management and GEMBA, as needed.
Support the corrective action program, as needed.
Support internal or external audit, as needed
Complete the assigned tasks, as needed.
TRAINING RESPONSIBILITIES: (REQUIRED)
- Complete all assigned and required training satisfactorily and on time
Education and Experience (in years):
High School degree (or equivalent experience) with 6+ years of related work experience ORAA or Technical Degree with 5+ years of related work experience.
Knowledge and skills:
Understanding of quality systems and principles.
Understanding of Good Documentation Practice.
Excellent verbal and written communication skills in group or one-on-one settings.
Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.
Understanding of general mathematical principles and calculations, at college entry level.
Ability to perform routine statistical applications.
Experience in compiling data to support metrics analyzing current process.
Understanding general laboratory failure investigation, qualification/validation process, root cause analysis, and troubleshooting principles.
Computer skills: Microsoft Office: word, excel, access, power point, Microsoft project; Agile, SmartSolve, MES and XpertERP.
Preferred Bachelor’s degree with 6+ years of related work experience.
Experience in DNA diagnostics or other medical devices
Experience in Kaizen, Problem Solving Process (PSP), Key Performance Indicator (KPI), Daily Management (DM), and GEMBA.
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .