Sr. Supplier Quality Engineer

Abbott Laboratories • Scarborough, ME

1d • $78,000 - $156,000

About The Position

In this role, you will partner with suppliers and internal customers to identify and implement effective process control systems that support the development, qualification, and ongoing manufacturing of supplied materials. This position ensures supplied materials meet or exceed both internal standards and external regulatory requirements.
Supplier Quality Leadership
Partner with suppliers and internal stakeholders to support development, qualification, and manufacturing of supplied materials
Identify, implement, and maintain effective supplier process controls
Ensure compliance with internal quality standards and applicable external requirements
Product Stewardship – Supplier Quality Lead
Implement and sustain a Product Stewardship program at the Maine site
Develop and manage a robust campaign‑based program, including change management processes
Execute required Product Stewardship campaigns according to program schedules
IVDR – Supplier Quality Lead
Execute Supplier Quality IVDR deliverables in alignment with program timelines
Project & Communication Responsibilities
Evaluate and define project scope, deliverables, and timelines
Deliver on commitments while managing multiple initiatives
Communicate effectively with both internal teams and external partners
Resource Management
Manage and oversee 1–2 contractors supporting Product Stewardship and IVDR activities

Requirements

• Bachelor's Degree in Engineering or Technical Field
• Minimum 5 years of Engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Solid communication and interpersonal skills.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing.

Nice To Haves

• Demonstrated supervisory experience preferred
• Prior medical device experience preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• ASQ CQE or other certifications preferred

Responsibilities

• Assist in the development and execution of streamlined business systems which effectively identify and resolve supplier quality issues.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving supplier quality issues.
• Partner with supplier & internal SMEs to design and conduct experiments for process optimization and/or improvement.
• Appropriately document experiment plans and results, including protocol writing and reports.
• Partner with supplier & internal customers to ensure effective process control and monitoring of supplied material CTQ parameters and specifications Complete work order documentation.
• Partner with supplier & internal SMEs to implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
• Perform quality checks.
• Lead the investigation, resolution and prevention of supplier related product and process nonconformance.
• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Supplier Quality function as a Core Team Member)
• Troubleshoot equipment issues.
• Lead in the completion and maintenance of supplier & component risk analysis.
• Partner with internal customer and the supplier in the completion of component verification and validation.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Performs other related duties and responsibilities, on occasion, as assigned.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level