Quality Engineer II

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 Summary:

• A Quality Assurance Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.

Job Duties:

• Execute and provide on-time completion of Quality Assurance engineering deliverables.
• Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action), Internal Customer Signals (ICS), and product Requests for Analysis (RFA).
• Works with key stakeholders to develop and maintain procedures and forms for the CAPA, product RFA, and ICS systems.
• Develop and lead training for CAPA, RFA, and ICS systems.
• Guide Quality Engineers and Supplier Quality Engineers with product review and analysis for CAPA, ICS, and RFA activities.
• Maintain databases and record storage for CAPA, RFA, and ICS systems. Process requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
• Lead meetings and communications for CAPA, RFA, and ICS system information, concerns, and updates.
• Lead CAPA, ICS, and RFA detailed data analysis, trending, and reporting. Publish weekly, monthly, and quarterly metrics.
• Track manufacturing related complaints in alignment with SJM goals.
• Plan ahead for various data storage needs and communicate plans clearly to prevent potential system issues.
• Seeks out information independently and able mentor/coach other members of the organization on CAPA, ICS, and RFA practices.
• Support Global CAPA team with training, CAPA oversight, and CAPA deliverables.
• Present CAPA, ICS, and RFA System to internal and external auditors. Investigate and resolve system nonconformances and concerns (defined during internal and external audits).
• Participates in or leads in the completion of risk assessments.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  Note: The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and requirements, which may change from time to time based on business needs. This job description supersedes any previous job descriptions with the same or similar title. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, national origin, marital status, age, citizenship, protected veteran status, sexual orientation, gender identity and/or gender expression, status with respect to public assistance, or disability status.
• Performs other related duties and responsibilities, on occasion, as assigned.

Equipment:

• Works with standard office equipment, telephone, cellular phone, and personal computer. Operates a motor vehicle for trips to various Company sites and outside vendor, field, and customer locations; and to commute to various airports for airline travel.

Working Conditions:

• Works at a desk in a well-lighted, air-conditioned office or workstation with a low to moderate noise level. Travels between company facilities via automobile; air travel as needed.

Physical Demands:

• Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.

Qualifications:

• Bachelor level degree in Engineering or Technical Field, advanced degree preferred.
• 2+ years technical experience
• Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies