Sr Quality Engineer
9775 Toledo Way Irvine, CA 92618 US
HM's Top Needs:
- Process Validations (PQ, OQ, Process Characterization, DOE)
- Statistical Analysis (Tolerance Interval, ANOVA, Sampling), Heavy experience with Minitab
- Lean Six Sigma, Root Cause Analysis, Problem Solving Techniques
Education Required: MUST HAVE - Bachelors in Biomedical Engineering or Engineering (Industrial, Mechanical, Electrical, Chemical)
PREFERREED – Masters in Engineering or Sciences
Years’ Experience Required: At least 3-4 years of engineering experience in a medical device manufacturing company
Specific Needs for the Project Include, but not limited to:
- Update RMW documents such as process FMECA, Drawings, Procedures and/or update Manufacturing Procedures (MP)
- Create and/or update Inspection plans on QAD system or SAP system
- Working knowledge with statistical tools and techniques to support and analyze data from DOEs, PC studies, and historical data
- Characterization of material to develop proper test methods.
- Create and/or update manufacturing Test Methods (TM)
- Execute Test Method Validations (TMV) for commercially released products.
Responsibilities may include the following and other duties may be assigned. Develops modifies applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment conducts quality assurance tests and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design incoming material production control product evaluation and reliability inventory 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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