Austin, Texas, 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
Basic Qualifications:
Bachelor’s degree in life science, engineering, or other technical discipline
5-10 years relevant experience working in pharmaceutical/medical device quality systems management with 5+ year’s management experience
Qualified lead or internal auditor
Preferred Qualifications:
Strong written and verbal communication skills
Positive, people-oriented, energetic attitude and able to work in a fast-paced environment
Self-motivated, highly organized, and able to prioritize and manage multiple tasks
Experience working in a manufacturing and/or production environment
Experience implementing and executing within ISO 9001, ISO 13485, US FDA 820, complaint Quality Management Systems
Expertise in risk management, root cause investigation, corrective/preventive action, and data analytics practices, tools and principles
Experience developing long-term strategic goals
Experience establishing operational objectives and work plans
Experience establishing and assuring adherence to budgets, schedules, workplans, and performance requirements.
Strong computer skills (MS Office, Visio, Project) and experience with quality management system software e.g., SAP, Agile, QCBD, MasterControl, Trackwise
Working knowledge of current industry quality practices under QSRs, ISO 9001 and international regulations required
Physical Requirements:
Performs work on site in Austin, Texas
Work is performed in a typical office work environment
Possible exposure to mechanical, biologic and chemical hazards
Must adhere to additional PPE and safety controls to prevent the spread of COVID-19