One of our clients in the medical device field is seeking a Senior Principal Quality Systems Specialist. In this role, you will take charge of overseeing and managing both internal and external audits of the quality management system. Your responsibilities will include organizing and facilitating audits, conducting follow-up activities, and developing quality programs to ensure adherence to policies. You'll also ensure that service quality and performance align with established internal and external standards and guidelines.
- Lead the preparation for internal and external audits and inspections. Manage the resolution of findings and maintain communication with auditing groups and inspectors throughout all audit stages.
- Offer expertise and guidance in interpreting policies, regulatory frameworks, and internal rules to ensure compliance.
- Provide supervision for the creation, maintenance, and enhancement of quality audit programs, systems, processes, and procedures. These will ensure compliance with policies and uphold service quality in line with established standards and guidelines.
- Collaborate directly with various functions to continually analyze processes, enforcing requirements, and meeting regulations.
- Oversee actions related to audit processes, ensuring prompt and effective resolution.
- Prepare reports and necessary documentation (such as Corrective and Preventive Actions) and distribute them to relevant internal and external stakeholders.
- Manage legal requests related to government investigations or legal matters.
- Foster uniform standards globally, encouraging the sharing of best practices. This contributes to the company's global mission accomplishment.
- Bachelor's Degree
- Minimum of 10 years of relevant experience. Alternatively, an advanced degree with a minimum of 8 years of relevant experience is acceptable.
- Prior experience in program management.
- Experience dealing directly with external regulatory bodies during audits.