The Quality Manager provides leadership and oversight in the Austin facility which manufactures reagents and kits for Food & Feed Safety, Next Generation Sequencing, and COVID qPCR. The position ensures that processes needed for the quality management system are established, implemented, and maintained; reports to top management on the performance of the quality management system and any need for improvement; and ensures the promotion of awareness of customer and regulatory requirements throughout the organization.

Essential duties and position responsibilities:

• Together with the global Quality, Regulatory and Medical Affairs (QRM) team drives a culture of quality

• Acts as the knowledge expert on ISO 9001, ISO 13485 Medical device, and GMP requirements

• Provides Quality Team support by promoting Good Manufacturing practices and supporting achievement of annual site objectives necessary to successfully produce and support Research Use Only and Emergency Use Authorized products and services

• Apply risk management skills and creative customer-focused solutions necessary to support the safety and effectiveness of our products and meet business objectives in a compliant and timely manner

• Applies in-depth business knowledge to provide strategic methods and techniques to business goals and objectives.

• Assures adherence to budgets, schedules, work plans, and performance requirements

• Ensure all Risk Management activities are executed and maintained according to all regulatory standards.

• Represent Quality for new and existing product development, manufacturing transfers and quality plan initiatives.

• Develop and foster strong relationships with key stakeholders within the facility and within broader PerkinElmer.

• Work on assigned projects, including corporate projects, with limited supervision

• Prepare for and Host FDA, USDA (AWA), ISO and Customer audits and inspections

• Manage Quality Management Review

• Actively participate in Operations and other business review meetings

• In conjunction with the Regulatory Affairs department, work to facilitate domestic and international regulatory requirements and registrations.

• Manage the corrective and preventative action process.

• Collect, analyze and report data from Nonconformities, Deviations, CAPA

• Manage the complaint handling process to ensure timely analysis, investigation and closure of complaints as well as reporting MDRs and Adverse Events, as necessary

• Ensure the effectiveness of QMS training program

• Manage Incoming Inspection, Material Review Board, and Change Control Board processes

• Manage responsibilities in association with final product release

• Manage the internal audit schedule and process; maintain all records of internal audits and respond to findings as necessary