The Senior Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on roll where the Sr. Quality Assurance Engineer will apply diversified knowledge of engineering, quality principles and practices for research use only products and in vitro diagnostic devices (EU and FDA). 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 management system in accordance with FDA Quality System Regulation and ISO 13485 requirements.
- Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, complaint investigations, NCs 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.
- Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
- Assist in review and approval of software user acceptance testing.
- Support method validation activities.
- Provide QE support to production, purchasing, and engineering.
- Conduct and support the development validation of appropriate test methods for product and process performance.
- Develop and initiate sampling procedures and statistical process control methods.
- Support product line manufacturing and design stages by ensuring validation of manufacturing equipment and processes are conducted in accordance with the Validation Master Plan.
- Evaluate product changes for qualification and validation requirements and assist in change implementations.
- Collaborate with Engineering on the calibration and preventive maintenance program.
- Adapt rapidly to a changing industry and be able to adjust responsibilities, time and objectives accordingly.
- Perform other duties & projects as assigned.
- Position is not remote and will require onsite interaction
- Ability to travel 10%.
Education and Job Experience
- Bachelor's degree in Engineering is required.
- A minimum of 7 years quality assurance/engineering experience is required.
- Experience in Quality Assurance/Regulatory requirements in medical devices, IVD, EU IVDR/MDR, pharmaceuticals or biotechnology industry.
- Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required.
- Experience and knowledge of Next Generation Sequencing, Synthetic Biology Manufacturing, and Gene Manufacturing highly desirable
- Experience with non-conformances, CAPA, and Risk Management is required.
- Experience with software user acceptance testing.
- Experience with equipment validation, method validation, and process validation.
- Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes).
- CQE, CQA preferred.
- Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience) required
- Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required
- Good interpersonal and communication skills
- Ability to work as part of a team
- Ability to review, analyze, summarize, and interpret data, draw conclusions and make appropriate recommendations and decisions; write reports
- Ability to create and provide training
- Good statistical and numerical ability
About Twist Bioscience
At Twist Bioscience, we work in service of customers who are changing the world for the better. In fields such as medicine, agriculture, industrial chemicals and data storage, by using our synthetic DNA tools, our customers are developing ways to better lives and improve the sustainability of the planet.
Twist Bioscience Corporation is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.