Quality Engineer I
Abbott Laboratories – Portland, OR
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 103,000 colleagues serve people in more than 160 countries.
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.
- 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.
- Performs other related duties and responsibilities, on occasion, as assigned.
- Bachelor level degree in Engineering or Technical Field, advanced degree preferred.
- 0-2 years technical experience
- Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies preferred
- Solid communication and interpersonal skills
- Advanced computer skills, including statistical/data analysis and report writing skills
- Prior internship or co-op experience preferred
- Six Sigma root cause analysis/problem solving training and experience preferred.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 10%, including internationally.