About Abbott
Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals - that create more possibilities for more people at all stages of life.
Today our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve.
12 month FTC
Position Summary:
Be a leader in design control and build organisational capabilities across ID design sites.
Embed Design Assurance in all stages of the design control process from concept and feasibility through to product launch and post market surveillance.
Review and remediation of current Design Control procedures and practices across sites to standardise to “best in class” design controls. Liaise with quality systems, R&D, clinical and medical affairs and regulatory affairs personnel within the Business Unit to ensure team’s compliance and to drive alignment and harmonization.
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 behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
- Perform other duties and projects as assigned.
- Development of effective training collateral to ensure compliance to design control policies with the Core Teams, Extended teams and relevant functions within the Business Unit.
- Champion and implement clinical compliance processes to support clinical operations and ensure that regulatory and ethics boards requirements are met through clinical studies.
- Provide Design Assurance Core Team Oversight and direction.
- Perform technical reviews of design documentation and labelling, attend at core team meetings and design reviews, coordinate and facilitate completion and update of design risk management documentation and act as independent reviewer for all design activities including design changes.
- Provide oversight on the development of new products and appropriate verification and validation activities.
- Provide direction on anomalies identified in design deliverables through data-based investigation and robust corrective action.
- Design Control Support for audits including Abbott Corporate Audits and external Regulatory/ Governing Body audits (e.g. FDA/ WHO). Take the lead and front the team’s participation in audits.
- Lead the creation and maintenance of the project design history file.
- Support development of user needs and translation into requirements.
- Manage a team of Design Assurance Engineers as the organisation grows and develops.
- Demonstrate ability to work is a matrix organisation where project deliverables are accountable to the Program/ Workstream Leader.
- Proven ability to lead a team.
- Travel pending company policy, global and country regulations to Asia and Europe.
Education / Experience / Skills
- Primary Degree level qualification in Science, Engineering or Technology, plus 10 years of Quality Engineering/ Design Assurance work experience within a regulated environment (ISO13485/ FDA) most recently within the area of design controls.
- Excellent presentation skills to facilitate communication throughout the organisation. In addition, excellent use of virtual communication technology is required for effective workshop leadership and change management.
- Formal training in Medical Device Risk Management, Clinical Evaluations, Process Validation and problem Solving would be beneficial.
- Excellent data analysis skills.
- Demonstrated experience in working in a diverse cultural environment
