Development Quality Engineer II

4 days ago

St Paul MN United States ICONMA, LLC Full time

Our Client, a Medical Device and Healthcare company, is looking for a Development Quality Engineer II for their St. Paul, MN location.

Responsibilities:

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.


Requirements:

Bachelor level degree in an Engineering Discipline or other technical field.
Hiring Manager is seeking a candidate that has 1-4 yrs. of work experience. Anyone more then 4+ years he is not interested in seeing due to candidate being overqualified.
Candidates that have worked in the Medical Device Field Experience is a plus.
NCMRS
CAPA'S
Any process Validation Experience
Operations Quality Design
Development Quality
Verbal and written communication
Interpersonal, teamwork, individual contributor
Multitask, strong organizational experience


Why Should You Apply?

Health Benefits
Referral Program
Excellent growth and advancement opportunities


As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.

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