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Director of QA
| PostId | a453a2c7-2d5e-4698-bb9a-ea2126c8ef43 |
| Posted Date: | 7/30/2010 |
| Job Category: | Quality |
| Salary Range: | DOE |
| Location: | Bay Area (South Bay) |
| Description: | Job Title: Director, Quality Assurance Reports to: President and CEO Job Grade/FISA Status: Exempt General Summary: Plans, coordinates, and directs quality assurance program designed to ensure quality production of medical device products consistent with established standards by performing the following duties. Essential Functions: • Formulates and maintains quality assurance objectives complementary to comply with ISO standards. • Develops and maintains system level as well as floor level quality procedures used throughout the company. • Performs quality engineering reviews of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records. • Develops product, group and company quality metrics. Establishes goals and takes action to meet goals. • Reviews and acts upon all data obtained during all quality assurance activities to ensure consistency with company policies and procedures. • Develops new approaches to solve problems identified during quality assurance activities, • Keeps management team abreast of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation. • Prepares and presents technical and program information to the management team. • Plays an active role on quality management teams within the organization. • Investigates and adjusts customer complaints regarding quality. • Manage and review Technical File/Design Dossier processes for European agencies/Notified Bodies. • Participate on cross-functional reviews of design, manufacturing and quality projects and processes. Skill Requirements: • Analytical - Collects and researches data; uses intuition and experience to complement data; designs work flows and procedures. • Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations. • Project Management - Develops project plans; coordinates projects; communicates changes and progress; completes projects on time and budget; manages project team activities, • Interpersonal - Focuses on solving conflict, not blaming; listens to others without interrupting; keeps emotions under control; remains open to others' ideas and tries new things. • Oral Communication...- Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions. • Written Communication - Writes clearly and informatively; presents numerical data effectively; able to read and interpret written information. • Managing People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates' activities; makes self available to staff; provides regular performance feedback; develops subordinates' skills and encourages growth; solicits and applies customer feedback (internal and external); improves processes, products and services. • Quality Management - Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness. • Business Acumen - Understands business implications of decisions; aligns work with strategic goals. • Cost Consciousness - Works within approved budget; develops and implements cost saving measures; conserves organizational resources. • Adaptability - Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events. • Dependability - Takes responsibility for own actions; keeps commitments; commits to long hours of work when Education/Training/Experience Requirements: • Demonstrated knowledge of domestic and international statutory regulations (e.g., 21CFR, MDD) and voluntary standards (e.g., ISO 13485, ISO 14971) • Master's degree (M. A.) or equivalent, plus five years' related experience. |