Development Quality Engineer II

Profile

We are seeking a Development Quality Engineer II for a very important client.

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.
Requirement:
The ideal candidate will possess the following qualifications:

Years Experience: 2-5

Skills: Verbal and written communication, interpersonal, team work, individual contributor, multi task, strong organizational, advanced computer skills

Software Quality Engineer
-remote, but need to have the ability to go into the office if needed
-possibility of extension or conversion
-agile development environment
-BS degree ideally Engineering or Computer Science
-working on a product related to imaging, cardiac focus
-focused on reviewing software documentation that relates to that deviceso
-will be generating risk management documents
-integrating in SDLC, providing alignment and compliance w/ quality management systems
-cybersecurity background is a plus
-exposure to windchill, JIRA
-Med Device is a must have
-experience w/ process validation is a nice to have
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