Sr Quality Engineer
195 McDermott Road No Haven, CT 06473 US
Job Description
Top 3 technical skills that are required for the role:
- Design Failure Modes and Effects Analysis Development
- Critical to Quality and Critical to Function understanding from Design, Part, Component, Assembly Perspective
- Reliability Test Method Development / Strategy / Statistical Analysis
Education Required:Â Bachelors degree in Engineering, Science or Technical field with 4+ years of experience in Quality and/or Engineering OR Advanced Degree in Engineering, Science or Technical field with 2+ years ofexperience in Quality and/or Engineering
Years’ Experience Required: 4+ Years in Quality / Engineering
The Senior Quality Engineer position on the team supports new product development for various product families in the Surgical Innovations Business. In this role the Quality Engineer works as part of the quality team supporting the cross-functional core team. An understanding of Conducting/Leading/Developing the Design Failure Modes and Effects Analysis the Critical to Function Matrix Risk Management process per ISO 14971 Design Verification Protocol and Report Development and Review Design Validation Protocol Development and Review Reliability Test Method Development/Setup/Analysis Develop/Conduct Reliability studies and evaluations Mechanical and Electro-Mechanical Design Reliability Test Development Electromagnetic Compatibility EMC Requirements/Testing/Development. As an important member of our Quality Team you will provide guidance and implement strategies that drive product quality and continuous improvement.
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TECHNICAL SKILLS
Must Have
- 2-5 Years Experience in Quality with BS in Engineering
- Bachelors degree in Engineering, Science or Technical field with 4+ years of experience in Quality and/or Engineering OR Advanced Degree in Engineering, Science or Technical field with 2+ years of experience in Quality and/or Engineering
- conducting dFMEA
- CTQ Analysis
- Design Failure Mode Effective Analysis
- develop CTQs
- Develop DFMEA
- monitoring of CTQ parameters and specifications
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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. Leads the Development Facilitation and Collaboration of Deliverables such as DFMEA Design Failure Modes Analysis Crtiical to Quality CTQ Component / Part Feature Criticality Development Engineering Testing/Development Design Verification and Validation Risk Based Design Verification and Validation Risk Management Understanding.
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.
DIFFERENTIATING FACTORS
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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