Development Quality Engineer II

Title: Development Quality Engineer II

Location: St. Paul, MN

Duration: 12 Month Assignment

100% Onsite

Position Summary:

We are seeking a Development Quality Engineer II to join our Structural Heart team at our St. Paul, MN location. The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will support new product development projects as well as support sustainability of commercially released product. This position may also support manufacturing processes to meet daily production schedules while enhancing productivity and product quality.

Responsibilities:

• Support and ensure internal & external audit responses and on-time product re-certifications.
• Author and revise procedures, controlled forms, and related documents to ensure best practices and compliance to regulatory requirements.
• Participate in CAPA process including the investigation of failures, as required.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaborate with all levels of employees, customers, contractors, and vendors.
• Support all divisional initiatives as identified by divisional management, including support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Additional duties may be identified by functional management based on current project/business objectives.

Required Qualifications:

• Bachelor’s degree within Engineering, Chemistry, Biotechnology, Life Science, or other technical field.
• 2-5 years of engineering experience and demonstrated use of quality tools/methodologies.
• Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
• Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives. Ability to quickly gain knowledge, understanding or skills and is willing to learn.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Ability to multitask, prioritize and meet deadlines in a timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel occasionally (<5%), including internationally.

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.