Careers at Hansen Medical
Sr. QA Specialist, Product Quality
SUMMARY:
Under minimal supervision, interface with Materials, Engineering and Production departments regarding Catheter production/release activities for clinical and commercial product.
RESPONSIBILITIES:
- Review device history records for compliance to standards; work with Catheter Production to resolve documentation issues
- Assure finished products conform to government and company standards satisfying the QSR, ISO, Canadian and other relevant foreign requirements
- Enforce corrective actions necessary to assure conformity to quality specifications
- Write or revise Standard Operating Procedures
- Perform environmental monitoring in the cleanroom and generate required Environmental Reports
- Support Production and Shipping schedules
- Provide input to ensure continuous improvement to product /process and systems
- Participate in assessment, evaluation and closing of non-conformances
- Participate in Material Review Board (MRB) activities as needed
- Participate in internal audits as needed
- Perform other relevant tasks as assigned
REQUIREMENTS:
- Proven mastery of all aspects of the quality process, including standards, methods and procedures
- Solid organizational, analytical and problem solving skills
- Strong computer skills, particularly with MS Excel and MS Word
- Excellent interpersonal and communication skills, both verbal and written
- Training in Quality Systems including QSR, MDD, Canadian and ISO 13485:2003
- B.S. in Engineering or equivalent Scientific discipline
- 3-5 years of Quality-related experience in the Medical Device industry
- Additional peripheral experience in Catheter - Production, Engineering and/or Product Development and Cleanroom environment is preferred
- Able to identify and report non-conformances
- Working knowledge of Good Manufacturing Practices (GMPs) & Quality System Regulations (QSRs)
- Experience in Quality Document review and release procedures
- SPC, electronic batch records and bar coding experience a plus
Please submit your information to: recruiting@hansenmedical.com
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