The Quality Assurance Validation Engineer will lead the development and implementation of statistical tools and procedures in a risk-based lifecycle approach to software, processes and analytical methods validation program within a medical device/cGMP regulated environment.
- Develop and implement a robust statistical techniques policy and SOPs
- Work with the QC group to establish statistically significant sampling plans and respective documentation
- Develop statistically significant acceptance criteria and justification
- Review validation and qualification documentation
- Execute validation/qualification activities, gather/analyze data and report
- Apply DOE in establishing ranges of incoming component quality, equipment parameters, and in-process material quality attributes.
- Ensure appropriate procedures, processes and policies are established and implemented for quality assurance activities to assure compliance with applicable medical device regulations and products.
- Educate, train, advise and coach other employees to ensure adherence to all applicable quality standards for assigned areas.
- Work with PD/OPS/MFG groups to establish a program to collect and analyze product and process data to evaluate the state of control of the process/es.
- Understand sources of variation
- Detect the presence and degrees of variation
- Understand the impact of variation in the process and ultimately on product attributes
- Control the variation in a manner commensurate with the risk it represents in the process and product.
- Participate in the Process Performance Qualification (PPQ) conformance lot manufacturing that includes increased testing to demonstrate the acceptability of the developed formulation and process. The testing should be commensurate with the risk identified for the product and process.
- Experiment at laboratory or pilot scale that may assist in the evaluation of conditions and prediction of process performance.
- Responsible for the development of metrics that report on the effectiveness of processes, status of improvement opportunities and progress against performance objectives to drive Continuous Improvement.
- A degree in Statistics or in Biomedical Engineering or equivalent combination with suitable experience in a statistical/validation job.
- Thorough knowledge of statistical applications in a pharmaceutical or medical device regulated environment.
- Practical application of risk management commensurate with the respective statistical significance of risk rankings and definitions.
- Knowledge of Quality System regulatory requirements.
- Physicochemical bio-engineering principles applied to pharma and/or medical devices.
- Utilities, facilities, equipment qualification
- Software validation
- Process validation
- Risk Management (ISO 14971)
- Design of Experiments (DOE)
- Studies in formulation and process development
- Statistical metrics in PQ
- IOPQ documentation development, execution and reporting.
- ASQ/ Six Sigma certification or equivalent is a plus
For More Information please contact
Tim Swanson email@example.com
Sarah Applebaum firstname.lastname@example.org