Sr Quality Engineer
12230 World Trade Drive San Diego, CA 92128 US
Additional position detail from the manager:
- Can you please confirm your top 3 skills sets required? Design Controls, Risk Management, Regulations/Standards knowledge; Experience with ISO 14971
- What is your target years of experience? 5
Responsibilities may include the following and other duties may be assigned. Develops modifies applies and maintains quality procedures and documents in compliance of regulations and standards. Product Risk management file development and maintenance. Ensure corrective and preventive measures meet acceptable standards of robustness and effectiveness. In collaboration with RampD ensure product design history file is developed and maintained. May specialize in the areas of design incoming material production control product evaluation and reliability product traceability and control and/or research and development as they apply to product or process quality.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.
Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties . Makes improvements of processes systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts statuses ideas and issues to achieve objective and influence decisionmaking.
Leadership and Talent Management: May provide guidance coaching and training to other employees within job area. May manage projects requiring delegation of work and review of others' work product .
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.
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