Personalis is a rapidly growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient’s cancer and immune response. Our ImmunoID NeXT Platform® is enabling the development of next generation immuno-oncology therapeutics and diagnostics.
The Sr. Quality Engineer plays a key role in the Quality Assurance & Regulatory Compliance team. The Sr. Quality Assurance Engineer maintains and supports compliance with applicable regulatory requirements. Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for class II and class III medical devices and combination products. This position also ensures that the company complies with all applicable federal, industry, and company procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.
- Maintain and improve the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
- Perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures).
- Develop and execute the validation master plan, validation project plan, risk assessment, user requirements, design qualification and life cycle documents for any improvements in the production methods and ensure compliance with cGMP regulations.
- Generate the User Requirement Specifications and Impact Assessments to ensure the functioning of the equipment and determine the impact of the system on the product quality.
- Perform design review to ensure the equipment is installed and operates according to the User Requirement Specifications.
- Perform Commissioning, Qualification and Validation of the equipment and systems.
- Generate and execute validation protocols (IQ, OQ and PQ) for manufacturing and laboratory equipment, including but not limited to HEPA filters, controlled temperature units, and manufacturing equipments.
- Characterize equipment operation processes and define critical process parameters and critical quality attributes
- Write and execute the official test scripts, complete associated documentation for equipment and processes to ensure the test results are reported accurately.
- Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
- Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
- Lead the resolution of quality issues related to non-conformance reports and CAPAs
- Provide Quality support to production and engineering
- Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan
- Oversee calibration and preventive maintenance program
- Evaluate product changes for qualification and validation requirements and assist in change implementations
- Other duties/ activities may be necessary to support departmental or company goals
- Minimum education required: BS/MS in a Engineering discipline
- Minimum experience required: 7+ years of experience
- Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required
- Experience with non-conformances, CAPA, and Risk Management is required
- Experience in performing test method validation and Gage R&Rs
- Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
- Excellent organizational skills
- Results and decision driven
- Details oriented, thoroughness and accurate in performing assigned tasks
- Timely execute tasks and meet deadlines
- Ability to execute independently and as part of a team
- Proven ability to use multiple software tools
Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package.