Senior Director, Technical Quality

Organization: 
Cepheid - US
Job Location: 
Sunnyvale, CA
Job Description: 

The Senior Director of Technical Quality is responsible for leading activities in developing, validating and supporting new product introduction, quality control, material acceptance and stability activities for Cepheid components and products.Leads technical development of for inspection and testing of materials and components, for in-process functional testing, and for quality control of instruments and consumables, developing, maintaining and standardizing sampling plans and testing procedures for these materials and products.

This position also directs Quality Engineers in the development of new products and distribution of commercially-released products. Leads cross-functional product management and development teams and leads Quality representatives responsible for planning, execution and review of development processes. Applies knowledge of design control principles and product evaluation techniques to positively influence the development of new products and to ensure they are developed and manufactured in accordance with regulatory and customer requirements. Reviews and evaluates scientific and technical data as it pertains to product testing and product performance.

This position interacts with personnel at all levels and departments in the company to ensure full compliance with all product requirements and specifications to meet both company and customer expectations.

- Develop and implement Quality Control systems
- Effective leader supporting strong interactions with new product development teams
- Provide scientific expertise and support to Manufacturing and Quality operations on site
- Provide scientific expertise and support for product investigations, improvements, etc. to ensure continued compliance with regulations
- Ensure all lab operations meet current cGLP and Corporate compliance requirements
- Maintains oversight of corrective and preventive actions dictated by the results of testing conducted by QC
- Establish, validate, and maintain specifications and test procedures
- Establish, implement, and maintain a plan for achieving consistent quality of test results for materials and products submitted to the QC group for evaluation
- Provide and analyze quality metrics for the work performed by the QC group
- Analysis and interpretation of complicated data sets
- Day to day interpretation of product requirements and of test results obtained against these requirements
- Provide guidance to ensure that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review
- Develop risk analysis standards/leads risk analysis teams at appropriate points during product life cycle
- Identifies and manages corrective actions resulting from problem investigations
- Lead and coordinate communications with customers and suppliers to ensure requirements are understood and component/product performance is appropriately managed

- Advanced degree (PhD) in Biological Science
- 10 years progressive experience in Product Development, Product Transfer, or Quality Control in medical device or a regulated industry
- Strong leader who can develop the team and continuously meet internal and external customer needs
- Must have experience with the application of the principles of statistical analysis
- Strong computer skills and understanding of electronic document management systems
- Exceptionally strong team player with excellent interpersonal and communication skills, and experience working with end-users in a mentoring capacity
- Extremely detail oriented with strong organizational skills and high quality standards
- Self initiative, hands-on, motivated problem solver, ability to lead by example, and enthusiastic, optimistic outlook are characteristics strongly sought in this position

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