Development Quality Engineer II

Title:Development Quality Engineer II
Location:St. Paul, MN(100% Onsite)
Duration: 12months
Pay Range: $35/hr to $38/hr (On W2)

We are looking for a ?Development Quality Engineer II? to join one of our Fortune 500 clients.

Job Responsibilities:

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• Participate in or lead teams in supporting quality disciplines, decisions, and practices \t
• Lead on-time completions of design control deliverables \t
• Support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects \t
• Accountable for generation of process validation test plans/reports \t
• Accountable for generation of PDP design verification test plans/reports for product/system requirements \t
• Lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMEAs, and Cybersecurity risk assessments \t
• Lead identification of essential outputs and generate Essential Output reports \t
• Accountable for completion of labeling verification activities and labeling verification reports \t
• Work with process engineering in the completion of manufacturing process deliverables such as manufacturing procedures and inspection procedures \t
• Work with process engineering in the completion of process validation deliverables such as inspection and test method development and equipment qualification \t
• Work with design engineering in the completion of customer/system/product requirements \t
• Work with design engineering in the completion of product verification and validation \t
• Ensure DHF content completion, integrity, and regulatory / standards compliance \t
• Support device manufacturing activities from product concept through commercialization \t
• Collaborative communication resolving gaps \t
• Complete document change request reviews in a timely and objective manner \t
• 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 \t
• Assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements \t
• Assist in tech development and execution of streamlined business systems which effectively identify and resolve quality issues \t
• Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues \t
• Support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements \t
• Ability to maintain regular and predictable attendance on-site \t
• Additional duties may be identified by functional management based on the current project/business objectives

Education:

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• Bachelor level degree in an Engineering Discipline or other technical field experience \t
• 2-5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 1 year direct quality manufacturing support experience \t
• Experience in medical devices and associated regulations/standards \t
• Experience in process validation planning and execution \t
• Experience in inspection method validation or test method validation

Preferred Qualifications:

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• 2+ years in direct quality manufacturing support experience \t
• Experience in preparing risk assessments, FMEA, and other risk documents \t
• Experience with reflow and injection molding processes

We are looking for the candidate who are eligible to work with any employers without sponsorship.

If you?re interested, please click ?Apply? button