Supplier Quality Engineer

Title: Supplier Quality Engineer

Location: Lake Forest, Illinois

Duration: 8 Months

Responsibilities:

• The successful individual will conduct quality-related activities such as preparing compliant documents & records review of quality records, product labels and product specification documents and will help to support implementation of NPD projects within Abbott, Core Diagnostics.
• Collaborate with colleagues in Technical, Regulatory, Planning, Engineering and Operations to perform product changes, non-conformances, quality agreement revisions, product/process improvements & product launches.
• Build effective working relationships with Third Party Manufacturers (TPM) and globally based colleagues to enable successful problem solving and issue resolution.
• Contribute to and ensure timely achievement of overall New Product Development project goals and tasks.
• Support transition of TPM products to meet IVDR regulation
• Support External and Internal audits of Abbott sites responsible for TPM products.
• Independently manage daily work schedule to ensure assigned duties are completed on time.
• Ensure compliance to global policies and procedures through creation of compliant records and documentation.
• Review multiple data sources and records at the same time, to identify GAPs and follow leads to investigate solutions.
• Helps to provide GAP analysis, data sets and justifications in support of change.
• Ensure that assigned projects and tasks are performed to meet the quality requirements of customers, internal quality systems, internal & external auditors and other external agencies.
• Bachelor's degree Life Science, Pharmaceutical Science, Quality or closely related discipline OR relevant combination of education and experience. plus 5-8 years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience.
• Prior experience working in a Quality or Technical role in commercial cGMP healthcare facility. Experience in key quality processes such as Change Control, Supplier Control, CAPA, IVD Testing or in manufacturing processes would be advantageous.
• Good, general understanding of the standards and regulations of the healthcare industry
• Strong communicator and committed team player.
• Having a right-the-first-time focus and an excellent eye for detail is essential to ensure records generated or reviewed are accurate.
• Takes initiative and follows through with others to ensure tasks get completed on time.
• Ability to work independently, with globally based colleagues and with minimal management oversight. Abbott experience is a huge plus, Experience in a quality role, detail oriented, Root Cause Analysis, comfortable working both independently and in a team.

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.