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.
Primary Job Function
Oversee and provide direction to quality assurance group that supports engineering, on-market product, field service, and development. Accountable for achievement of compliance, financial and performance goals for strategic projects and QA group. Responsible for establishing, implementing, and maintaining the quality system including the quality policy, the quality plan, and the organizational structure to support the quality system. Ensures the appropriate level of staffing to implement quality policies, achieve quality goals and to comply with applicable site and division level policies; procedures and regulations.
Core Job Responsibilities
Responsible for quality assurance group that monitors on-market product performance through complaints and other sources, improves customer satisfaction and addresses product issues through risk evaluation and product actions. Interface with broad range of internal functional groups including operations, R&D, marketing, and field service. Serves as site quality liaison with Division and Corporate functions including Medical Event Group, Product Quality Assurance, and related functions. Maintain exceptional communication with Director Quality Assurance, General Manager and other senior business leaders on issues.
Responsible for communications with external regulators (FDA; Ministries of Health; Notified Bodies) as it applies to job responsibilities. Represents the site during internal and external audits in multiple areas including QA operations, complaint management, risk evaluation, market surveillance and vigilance activities. Responsibilities include advising senior management regarding action plans for events related to product quality and product safety.
Serves as a key quality representative for Corrective Actions Board to review and ensure appropriate content is documented in nonconformance and deviation reports. Make key decisions on product quality issues. Provide oversight for product non-conformance situations ensuring adequate investigation and corrective actions are in place to prevent future occurrences. Ensure non-conformances meet the requirements listed within the procedures; investigations are completed and product disposition is consistent with the conclusions of the documentation.
Develop quality strategies to achieve business objectives while ensuring compliance with global regulatory requirements. Implement and manage programs across the business unit to ensure improved customer satisfaction and compliance with regulatory requirements. Monitor customer complaint and service activity to address adverse trends that may impact customers and business. Provide feedback into product improvement initiatives using internal and external data. Translate customer needs into product and process requirements; review process and product designs to ensure that customer needs are met; identify issues affecting customer satisfaction and establish initiatives to address those issues and prevent defects.
Manage area consistent with long term business strategy; develop policies and procedures to implement and help shape the business strategy; initiate communication programs to ensure that strategy is communicated and known.
Coach staff and managers to assure long term success of area of responsibility. Review development plans of subordinates and ensure that development and impact goals are aligned with long term needs of the business. Provide development opportunities for staff and contribute to HR strategies. Prepare succession plans to support the business strategy.
Bachelor's Degree preferably in a technical/scientific discipline
Minimum of 8years of medical device experience in Quality, Regulatory and/or Technical
2+ years of direct supervisory experience
Requires practical knowledge and/or experience in complaints, market surveillance, and vigilance
Knowledge of regulations and standards affecting IVDs strongly desired.