Overview
Quality Engineer Jobs in Plymouth, MN at Collabera
Title: Quality Engineer
Company: Collabera
Location: Plymouth, MN
To discuss more about this job opportunity, please reach out to Himanshu Kumar Singh(LinkedIn URL – https://www.linkedin.com/in/himanshu-kumar-singh-57b782258/), email your updated resume at Email – [email protected] or give me a call at (425) 403-0902. Thank you!
Pay Rate: $30 – $36/hour
Position Details:
Industry: Medical Device
Job Title: Development Quality Engineer II
Location: Plymouth, MN 55442
Duration: 6 months (possible extensions)
Job Description:
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.
