Development Quality Engineer II Job Saint Paul area,Minnesota USA,Engineering

Development Quality Engineer II

Location:

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

Job 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 process validation test plans/reports
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, FMEAs, 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 process engineering in the completion of manufacturing process deliverables such as manufacturing procedures and inspection procedures
Work with process engineering in the completion of process validation deliverables such as inspection and test method development and equipment qualification
Work with design engineering in the completion of customer/system/product requirements
Work with design engineering in the completion of product verification and validation
Ensure DHF content completion, integrity, and regulatory / standards compliance
Support device manufacturing activities from product concept through commercialization
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
Ability to maintain regular and predictable attendance on-site
Additional duties may be identified by functional management based on the current project/business objectives

Education:

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

Preferred Qualifications:

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

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