Development Quality Engineer II

Abbott; Saint Paul (MN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account (HSA)

Flexible Spending Accounts

Life Insurance

Short Term Disability

Long Term Disability

Critical Illness & Hospital Coverage

MetLife Benefits (ID Fraud, Pet)

Job summary

Abbott in Saint Paul, MN is seeking a Development Quality Engineer II to join its quality organization on a 12-month assignment. The role focuses on design control, process validation, risk management, and ensuring regulatory compliance throughout product development.

You will participate in or lead teams, develop and execute test plans, and contribute to quality systems supporting PDP and cPDP projects, with on-site work from 8AM to 4PM.

Qualifications

• Bachelor's degree in engineering or a technical field required.
• 2-5 years 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 / test method validation.

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), clinical product development process (cPDP), and design change projects
• Accountable for generation of process validation test plans/reports
• Accountable for generation of design verification test plans/reports for product/system requirements
• Lead or support Risk Management activities from concept through commercialization, including risk management plans/reports and hazard analysis, FMEAs, cybersecurity risk assessments
• Lead outputs and generate Essential Output reports
• Accountable for completion of labeling verification activities and reports
• Work with process engineering on manufacturing and process validation deliverables
• Collaborate with design engineering on customer/system/product requirements and product verification/validation
• Ensure DHF content completion, integrity, and regulatory/standards compliance
• Support device manufacturing activities from concept to commercialization
• Resolve gaps through collaborative communication
• Complete document change reviews timely
• Identify and implement effective process control systems
• Assist in CAPA systems and process controls implementation
• Assist in streamlining business systems to identify and resolve quality issues
• Apply systematic problem solving to quality issues
• Support QMS, EMS and regulatory requirements
• Maintain regular on-site attendance
• Additional duties as assigned

Skills

Verbal communication

Interpersonal

Teamwork

Independent contributor

Multitasking

Organization

Computer skills

Education

Bachelor's degree in engineering or technical field

Job description

• 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 / test method validation
  

Title:

Development Quality Engineer II

Location:

St. Paul, MN

Duration:

12 Months

Shifts:

8AM TO 4PM

100% Onsite

Basic Qualifications

• 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 / 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 implant medical devices
  

Skills

• Verbal and written communication
• Interpersonal
• Team work
• Individual contributor
• Multi tasking
• Strong organization
• Advanced computer skills
  

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), clinical product development process (cPDP), and design change projects
• Accountable for generation of process validation test plans/reports
• Accountable for generation of 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 qualificationWork 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
  

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.