Development Quality Engineer II

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Job description

Job title: Development Quality Engineer
Location: Menlo Park, CA
Duration: 12 months (Possible extension)

Job summary
* Employee will be responsible for Development Quality deliverables including but not limited to: - Risk Management, FMEA - Verification, Validation and Shelf Life protocols and reports (Design and Process); inclusive of product bracketing assessment, configuration determination, sample size determination, statistical analysis and rationale, and oversight of V&V testing
* Test Method (in-process and finished good) development and validation - Inspection and Control Planning - General change management deliverables - Possible responsibility for CAPA process execution.
* Exempt/Non-Exempt: non exempt
Years Experience:
* 2-5
Skills
* Verbal and written communication, interpersonal, team work, individual contributor, multi task, strong organizational, advanced computer skills
Education
* Bachelor level degree in an Engineering Discipline or other technical field experience
Duties
* Participate in or lead teams in supporting quality disciplines, decisions, and practices
* lead on-time completions of design control deliverables, support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects, accountable for generation of PDP design verification test plans/reports for product/system requirements
* lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMECA's and Cybersecurity risk assessments
* lead identification of essential outputs and generate Essential Output reports, accountable for completion of labeling verification activities and labeling verification reports, work with design engineering in the completion of customer/system/product requirements, work with design engineering in the completion of product verification and validation, endure DHF content completion, integrity and regulatory & standards compliance, collaborative communication resolving gaps, complete document change request reviews in a timely and objective manner,
* Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements, assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements, assist in tech development and execution of streamlined business systems which effectively identify and resolve quality issues, apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues
* Support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements, additional duties may be identified by functional management based on the current project/business objectives. #LI-FRESH