JOB OBJECTIVE: Utilize quality principles and practices to manage and improve quality processes and ensure quality system compliance.
1. Design, develop, redesign and manage of quality system processes to ensure compliance with Quality System Regulation (QSR), ISO9001, and ISO13485.
2. Provide subject matter expert input into key quality processes including Change Control, Complaints, Nonconforming Product, and CAPA.
3. Oversee and monitor the change control system including processes, procedures, and records for compliance to requirements. Identify gaps, opportunities for process improvements, and facilitates communication for changes that could or may affect Promega operations, customers, or partners.
4.Work with users to initiate and complete change records.
5. Lead cross-functional work teams and improvement projects. Address delays and other barriers in completion of tasks.
6. Write or establish processes, metrics, or procedures to ensure continued process and quality system performance.
7. Design and implement training appropriate to the process or system implemented or improved.
8. Review data, documents and other quality records.
9. Understand and comply with ethical, legal and regulatory requirements applicable to our business.
1. Represent Promega in discussions/interactions with partners, vendors or customers, as requested.
2. Represent Promega in external audits, as requested.
3. Work with management on urgent/critical activities or actions needed for the business.
4. Conduct internal audits of the Quality System.
5. Conduct supplier audits of suppliers or partners.