Commercial Quality Manager

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, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Job Description

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• 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.

The Opportunity
Our molecular division delivers best-in-class innovative testing solutions for people around the world, providing answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions.

Position: Commercial Quality Manager
Location: AMD-Molecular Business Unit, Des Plaines, Illinois

Role Overview:

Our location in Des Plaines, Illinois is hiring for a Commercial Quality Director. This role will be responsible for ensuring that the region commercial affiliates implement and maintain cost effective quality system solutions and remain in compliance with regulatory requirements, fulfilling the commitments of the region/division or corporate compliance plans. Throughout establishing and maintaining quality assurance programs, policies, processes, procedures and controls with regard to:

• Quality Management System,
• Training related to the Quality System and GMP
• Change Controls, Exceptions and CAPA
• Quality Events Handling, Complaints, Product Actions, Significant events & Counterfeiting, Tampering, Diversion and Product Theft
• Supplier Management
• Quality Audit Program
• Material Control
• Risk Management
• Quality Projects

What You’ll Work On:

• Provide Quality Engineering leadership in direct support of medical device manufacturing.

• Management and development of Quality Engineers and Technicians.

• Manage the activities of the Post-Production Quality Engineering team.

• Responsible for managing operations across multiple countries and overseeing warehouse (WH) activities. Additionally, the candidate must be an expert in secondary packaging and labeling activities.

• Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.

• Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.

• Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.

• Define and implement superior Process Control & Monitoring systems for KPIV and KPOV throughout the product lines – Critical Parameter Management.

• Provide influential peer leadership with international partner site to drive proactive quality improvements.

• Identify Quality Initiatives and lead cross-functional teams to complete them.

• Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.

• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.

• Oversee the Non