Abbott Quality Engineer II in Plano, Texas
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
The 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.
• 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
• Detailed knowledge of FDA, GMP, and ISO 13485
• Solid communication and interpersonal skills
• Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
• Advanced computer skills, including statistical/data analysis and report writing skills
• Prior medical device experience preferred
• ASQ CQT, CQE, CQA certification 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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com