Senior Quality Engineer

at  Abbott Laboratories

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 113,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 5,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now support significant growth for Abbott in COVID-19 related products in over 70+ countries

PREFERRED QUALIFICATIONS

• Six Sigma root cause analysis/problem solving training and experience preferred.
• Significant CAPA management experience is essential and previous experience in mentoring CAPA owners preferred.
• Certified lead auditor (ISO 13485 or equivalent)
• Prior medical device experience preferred.

Basic Qualifications – Education / Experience / Skills

• Bachelor’s Degree or master’s degree in a science or technical discipline or equivalent combination of education and work experience.
• 5+ years’ experience in a significant Quality Assurance/Systems engineer role within a relevant regulated industry plus demonstrated competence.
• Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
• Certified lead auditor.
• 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.
• Ability to travel approximately 20%, including internationally.
• Ability to maintain regular and predictable attendance

THE ROLE:

• The Senior Quality Engineer works within the Infectious Diseases Business Unit Quality team. The Infectious Diseases Business Unit Quality team is responsible for implementing, maintaining and providing support and guidance in BU quality management system processes across ID, ensuring effective compliance in accordance with Abbott Quality & Regulatory (AQR), quality system and regulatory requirements.
• By liaising with Business Unit functions, you are responsible for supporting the development, deployment, maintenance and improvement of Nonconformance (NC) and CAPA Management processes within the ID BU, ensuring compliance to regulatory, corporate and divisional requirements. Completion of ID BU site and supplier audits in line with audit schedule (lead auditor).
• You will work closely with the ID entities globally and the Senior Manager, BU Quality Systems to ensure program deliverables are well communicated and implemented effectively. Travel will be expected, when necessary, to support ID sites.

KEY RESPONSIBILITIES:

• Carries out duties in compliance with established business policies and procedures.
• Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Supporting the Senior Manager, BU Quality Systems in the adoption of best practices for NC/CAPA within the BU to include, but not be limited to:
• NC/CAPA process improvement
• Mentoring site NC/CAPA execution
• Participate in, or lead, the completion of CAPA projects, assuring compliance, quality and timeliness of records.
• Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.
• Monitoring and analysis of NC/CAPA metrics to identify trends and Global CAPA management.
• Responsible for assisting with metrics and reporting on regular basis in accordance with established procedures.
• Working with cross functional working teams, conducts Global QI/CAPA Root Cause Analysis and establishes / implements effective resolution plans, as applicable. (e.g. Six Sigma root cause analysis/problem solving skills).
• Independently investigate, gathers data, and perform preliminary analysis.
• Lead meetings and communications for CAPA updates, information, and concerns.
• Coordinates and manages the BU CAPA Review Board, including inputs/outputs of the BU CAPA Review Board, ensuring global issues and required actions are effectively communicated to impacted entities and required actions taken.
• Assist in the initiation, processing and completion of CAPA records in Agile PLM.
• Authoring and maintaining ID BU quality policies, procedures, work instructions, forms, and templates to ensure that processes are compliant with Abbott Corporate policies, external quality standards/regulatory requirements and customer (Entity) requirements.
• Support other QMS activities as required by the Senior Manager, BU Quality Systems.
• Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.
• Execute and provide on-time completion of Quality Assurance engineering deliverables.
• Provide support and subject matter expertise during audits and inspections.
• Lead and/or contribute to continuous improvement initiatives and projects.
• Conduct audits within ID BU to support compliance and inspection readiness.
• Perform other duties and projects as assigned.

Basic Qualifications – Education / Experience / Skills

• Bachelor’s Degree or master’s degree in a science or technical discipline or equivalent combination of education and work experience.
• 5+ years’ experience in a significant Quality Assurance/Systems engineer role within a relevant regulated industry plus demonstrated competence.
• Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
• Certified lead auditor.
• 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.
• Ability to travel approximately 20%, including internationally.
• Ability to maintain regular and predictable attendance.