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Sr. Director of Quality Assurance
Pioneering Therapies, Transforming Lives. What does it mean to be part of the Thoratec Team? It means working in a fast-paced environment that inspires you. It means collaborating on projects that literally save patients' lives. We have an incredible opportunity for a Sr. Director of Quality Assurance to work with our innovative Quality team in Pleasanton, CA.
The Sr. Director of Quality Assurance will lead, establish, implement and maintain quality assurance systems and activities ensuring conformance with domestic and international quality system standards and regulations for commercial medical devices designed, produced and marketed by the Cardiovascular Division of Thoratec Corporation. This individual will also provide technical and organizational leadership to Quality / Quality Assurance programs and activities and expand the group by providing leadership and value-added services to the company. Partners with Operations R&D, and Program Management & Systems Engineering and others cross functionally to deliver highest quality products. The incumbent must be a strategic thinker, good communicator and possess the ability to inspire and lead others to achieve the critical mission of this vital functional area.
This position is responsible for, but not limited to, the following:
- Responsible for the strategy, administration, and direction of the Quality Assurance organization.
- Directs all aspects of Quality Assurance, using a well-grounded understanding of technical, scientific and regulatory issues. Directly supervises exempt department personnel up to the director level and exercises general supervision over all employees in the Quality Assurance organization.
- Manages the operating budget for the Quality Assurance operational and engineering groups.
- Has overall responsibility for the Quality Assurance Department, including Receiving Inspection, Supplier Quality Assurance, In-Process Quality Assurance, Sustaining and New Product Development Quality Engineering, Sterility Assurance and Microbiology activities.
- Functions as an integral member of the new product development team responsible for management of all pre-clinical and clinical studies.
- Provides Quality Engineering input during the Design Control, Design Review, and Design Transfer processes through review and approval of the applicable design control documentation.
- Participates in new product development team meetings, technical design reviews, and phase gate design review meetings to contribute quality assurance requirements and considerations.
- Leads quality planning activities for new product development.
- Leads risk management activities throughout the product lifecycle, including new product development and post production risk management.
- Manages Receiving Inspection team. Coordinates and communicates with internal Supply Chain Management and Manufacturing Engineering groups and external suppliers to ensure timely corrective action when purchased goods and services do not meet requirements.
- Ensures all inspection and testing as part of product acceptance activities preformed on behalf of the company comply with internal controlled procedures, and external quality system regulations and standards.
- Works with R&D and Manufacturing Engineering to assure the effective development and qualification of inspection and test methods and equipment.
- Regularly reviews quality system standard operating procedures and work instructions, making changes as necessary to ensure compliance and efficiency Quality Assurance processes.
- Provides input to the Management Review process for systems assigned to Quality Assurance. Responds to corrective actions assigned from Management Review meetings.
- Develops, administers, and maintains quality systems required to ensure the company's products are in compliance with quality standards as required.
- May lead FDA and other Agency factory inspections. Responds to nonconformities identified in internal and external audits, and to corrective / preventive actions assigned to Quality Assurance.
- Maintains oversight of the administration of all facets of sterility assurance and microbiology for new and current medical devices in order to assure compliance with internal and external requirements.
- May travel up to 20%.
- Bachelors of Science degree or higher required (engineering, technical, or life sciences field strongly preferred).
- Minimum of 15 years experience in the medical device industry, including medical device design, manufacturing, and management experience in a complex quality assurance / quality systems field.
- Demonstrated knowledge and understanding of the Quality System Regulations (QSR), ISO 14385:2003, requirements and other related regulations. Extensive experience working with International regulatory bodies and with the FDA.
- ASQ certification (CQE/CQA/CRE/CQM) or equivalent formal training and experience preferred.
- Ability to provide leadership to others in the organization through influence, innovative practices and teaching skills to foster a corporate culture that of responsiveness, compliance awareness, self-regulation, quality system ownership, challenge of status quo, and continuous improvement in order to achieve the highest level of compliance.
- Possesses excellent organizational, time management, and multi-tasking skills in order to meet commitments and deadlines.
- Highly developed oral and written interpersonal communication skills to effectively communicate with company management, customers, suppliers, and agencies at all levels.
- Proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., Quality Management System (QMS) software), Requirements Management software such as IBM DOORS), including software programs generating reports and statistics. Ability to create, use and interpret scientific tables, charts, and graphs..
- Competence in basic statistical methodologies and tools for analyzing data, and identifying and communicating the frequency, severity, and distribution of trends.
- Excellent problem solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues.
- Possesses a strong scientific and technical background, sufficient to establish credibility with senior management as well as the manufacturing and product development teams.
Why work for us?
For more than 30 years, Thoratec has been committed to developing advanced medical technologies to improve patient survival and quality of life. Thoratec provides the broadest mechanical circulatory support portfolio to treat the full range of clinical needs. From acute to chronic heart failure, Thoratec offers proven device-based therapies to provide a new beginning for patients and their families. We value people who are passionate about collaboration, creativity, and quality. We give back to our community and help people live healthy lifestyles through support, education, involvement, and participation.
Thoratec employs more than 800 people worldwide. We are based in Pleasanton, California, with facilities in Burlington and Waltham, Massachusetts; Sunnyvale and Rancho Cordova, California; Gainesville, Florida; Cambridgeshire, UK; and Zurich, Switzerland.
Thoratec Corporation is an Affirmative Action/Equal Opportunity Employer.