Senior Quality Engineer

• 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.

• 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.

• 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.

• 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.

• Advanced computer skills, including statistical/data analysis and report writing skills.
• 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 organisation.
• Multitasks, prioritises and meets deadlines in timely manner.
• Strong organisational and follow-up skills, as well as attention to detail.

Abbott