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 103,000 colleagues serve people in more than 160 countries.
As the Quality Assurance Supervisor, you will be responsible for the Product Quality Assurance (PQA) team supporting instrument, hardware and software products for the Dallas site; supervising an exempt team which supports complaints, risk evaluations, risk control measures, and other post-market surveillance and communication activities. You will spend time working to grow and develop team members, monitor and respond to field performance and customer feedback, ensure full audit readiness and milestones are achieved within budget.
Core Job Responsibilities:
- Responsible for implementing and maintaining the effectiveness of the quality system; Drive proactive quality within team to ensure audit readiness
- Drives continuous improvement in compliance through the maintenance of quality policies.
- Provides direct audit support including functioning as a PQA SME with auditors, and supervises audit-support activities
- Responsible for mentoring, conducting performance reviews, creating training plans and delivering training to team members, in addition to identifying staff development needs in areas such as GMP training, technical skills, safety, performance management and best practices.
- Identifies cause-effect relationships and uses technical/quality knowledge and experiences to recommend and execute action plans.
- Acts as a technical expert and approval authority on relevant technical issues, protocols, SOPs, methods, etc.
- Responds directly to requests for information from internal quality organizations and external regulatory agencies.
- Takes action to ensure the team, department, and overall GPQA organization meets the required goals and metrics.
- Manage quality discrepancies related to process, product, and customer complaints; and develops scope, disposition, and corrective actions for prevention of future discrepancies.
- Assist in the development of the plan (capital and expense) by identifying, leading, and implementing projects to improve processes, reduce costs, and maintain operations.
- Quantifies Risk by identifying the financial, quality, regulatory, and human considerations associated with decisions.
- BS or equivalent and 2-4 years of related operations experience.
- Experience should demonstrate the application of analytical and mathematical skills, and the ability to understand financial information or directly technical experience sufficient to demonstrate the knowledge typically associated with the degree and experience requirement.
- Knowledge of regulations and standards affecting IVDs and Biologics.
Preferred Experience, Education, etc.:
- Degree in Medical Technology, Engineering, or Sciences
- Experience in healthcare or healthcare industry, especially in the clinical laboratory
- Experience in customer support, complaint handling, and/or risk
- Ability to motivate and influence a team
- Effective verbal and written communication skills with the ability to summarize and present on complex technical topics
- Strong interpersonal skills and decision-making ability
- Ability to train, organize and supervise the efforts of a work group.
- Demonstrated capability of driving change