Development Quality Engineer II

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Deb Chatterjee at email address

We have Contract role Development Quality Engineer for our client at Plymouth, MN. Please let me know if you or any of your friends would be interested in this position.

Position Details:

Development Quality Engineer - Plymouth, MN

Location                         : Plymouth, MN - 55442

Project Duration        : 6+ Months of contract

Payrate                               : $34/hour on W2

Screening Questions:

• What is your experience with Design Control and Product Development Process (PDP/CPDP)?
• Have you created or worked on Design Verification test plans and reports?
• Can you explain your experience with DHF (Design History File) documentation?

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

To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Deb Chatterjee at email address

About generis tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.