Development Quality Engineer II

Title: Development Quality Engineer II

Location: St. Paul, MN 100% Onsite

Duration: 12 Months

Responsibilities:

• Experience required 2-5 years
• Verbal and written communication, interpersonal, teamwork, individual contributor, multi-tasking, strong organizational, and advanced computer skills.
• Education: Bachelor's level degree in an Engineering Discipline or other technical field experience
• 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 the 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, ensure 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 ongoing 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.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.