Senior Specialist Quality Assurance (Supplier Quality)

Abbott • Des Plaines, IL

23h • $78,000 - $156,000 • Onsite

About The Position

This position works out of our Des Plaines, IL location in the Abbott Molecular, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Senior Specialist Quality Assurance (Supplier Quality) will support in the selection, approval, and maintenance of the division's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities.

Requirements

• Bachelor's preferably in science, engineering or a closely related discipline, or an equivalent combination of education and work experience.
• Minimum 5 years relevant experience, such as Quality, Compliance, Engineering, within a regulated environment, such as medical devices, diagnostics, or pharmaceutical industries, to develop the competence required to meet the skills and responsibilities of the position.

Nice To Haves

• Master's degree preferred.
• Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices.
• Previous experience with audits and inspections.
• Strong working knowledge of ISO 13485 and regulatory requirements for medical devices
• Knowledge of quality management techniques and the application and principles of quality engineering.
• Strong knowledge and application of concepts, practices, and procedures.
• Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
• Understanding of statistics.
• Demonstrated initiative and problem-solving skills and critical-thinking skills.
• Ability and aptitude to use various types of databases and other computer software.
• Ability to prioritize.
• Strong organizational and project management skills.
• Ability or aptitude to influence without direct authority.
• Certified Lead Auditor trained.

Responsibilities

• Cross-functionally lead Supplier Quality Management process improvements which may include supplier change notifications, corrective action and preventive action (CAPA) activities, new product introduction support, quality audits, complaint investigations and supplier metrics and monitoring.
• Independently work to resolve complex issues.
• Analyze complex problems and identify their impact.
• Establish probabilities.
• Draw conclusions reflecting broad business needs.
• Ensure compliance.
• Work may require collaboration with other Division sites and/or other Abbott divisions.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Travel up to 25% domestically to support supplier management and goals.
• Understand and comply with applicable EHS policies, procedures, and guidelines.
• Works under general direction; independently determines and develops approach to solutions; work is reviewed upon completion for adequacy in meeting objectives.
• Makes timely and effective decisions related to business issues within scope of responsibility; appropriately elevates high risk issues / decisions; identifies and quantifies risks and their consequences relative to the success of a project / task; recommends appropriate action; decisions or recommendations would typically achieve departmental / project objectives.
• Drives functional performance that ensures cross-functional standards and expectations are met.

Benefits

• 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.

What This Job Offers

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