Quality Associate IV

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:

The Opportunity

The position of Quality Associate, under the supervision of the Lead or Supervisor, the scope of this position is responsible for carrying out the daily operations in the Quality department.

What You'll Do

• Familiar and capable of performing all responsibilities of the Quality Associate II and III roles.
• Subject Matter Expert in one or more specific Quality processes such as incoming inspection and/or change management and/or records (including batch release).
• May also support record administration and batch record review, including Certificate of Analysis / Certificate of Conformance creation for material lot release.
• Assign labeling and pre-production change requests to Change Management staff aligning experience with project load and complexity.
• Process IUO and IVD product labeling and the associated RMS change requests while ensuring compliance with company policies and procedures. Able to navigate complexity and troubleshoot issues with the most complex changes
• Assist labeling change owners and junior staff with the creation of design change plans.
• Able to leverage subject matter expertise to impart positive impacts on organizational outcomes.
• Support change packets per the approved procedures, including analyze change packets for impact to Device Master Records and for the associated maintenance of the DMRs.
• Able to independently correct issues and proactively identify future issues. Leverage expertise to improve future submissions via collaboration with change owners.
• Create and maintain the Design History Files per the approved procedures. Review records for good DHF documentation
• practices and adherence to the DHF Document Change Control requirements. Maintain the Master Action Item List, DHF. Index and the DHF History Index.
• Assist in the documentation of key processes and departmental procedures and well as participates on continuous improvement projects as assigned.
• Compiles and maintains data used for the creation of department metrics and reports. Able to own key local reporting responsibility and take the lead in areas of expertise, as appropriate.

Required Qualifications

• High School Diploma / GED
• Education Level: an equivalent combination of education and work experience.

• Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.

• Must be detail-orientated, self-motivated and available for flexible scheduling; Strong communication and problem solving skills.

Preferred Qualifications

• Bachelor’s Degree;
• Proficient with MS Office strongly preferred; >
• Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic
• Knowledge of Quality System Regulations.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority (Manufacturing roles only)
• Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only)
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.