We are seeking a highly skilled and experienced Senior Design Quality Engineer to join our team. This role will focus on design control and the product development process, with a particular emphasis on reagent and assay development.
Currently ISO 9001 certified, we are actively working towards ISO 13485 certification to further enhance our quality management systems. The successful candidate will play a critical role in upgrading our quality standards to ISO 13485, ensuring both rigor in product quality and flexibility in innovative RUO products. This person must be creative in problem solving, flexible in implementation approach, and relentless in driving product quality.
Key Responsibilities:
- Design and improve quality framework for Design Control to meet ISO 13485 standards with both rigor and flexibility in mind so that it works well for RUO and IVD products.
- Lead and manage design control activities for new product development, ensuring compliance with ISO 13485 standards.
- Collaborate with cross-functional teams, including R&D, Manufacturing, Quality Control, and Software, to develop and implement robust design control processes.
- Provide quality engineering support for reagent and assay development projects, including risk management, design verification, and validation activities.
- Develop and maintain design history files (DHF) and other documentation required for potential regulatory submissions and audits.
- Conduct design reviews and ensure that design outputs meet design input requirements and customer needs.
- Identify and mitigate potential quality and compliance risks throughout the product development lifecycle.
- Support the transition of products from development to manufacturing, ensuring that quality requirements are met.
- Participate in internal and external audits, providing expertise on design control and product development processes.
- Stay current with industry best practices, regulatory requirements, and emerging trends in quality engineering and life sciences.
Minimum Qualifications:
- Bachelor's or Master's degree in a relevant scientific or engineering discipline (e.g., Biology, Biochemistry, Biomedical Engineering).
- 7 years of experience in quality engineering, with a focus on design control and product development in the life sciences industry.
- In-depth knowledge of ISO 9001 and ISO 13485 standards and their application to reagent and assay development. Additional experience with instruments is highly beneficial.
- Proven experience in leading design control activities and managing design history files (DHF).
- Strong understanding of risk management principles and tools (e.g., FMEA, fault tree analysis).
- Excellent problem-solving skills and the ability to work effectively in a cross-functional team environment.
- Strong communication and interpersonal skills, with the ability to influence and collaborate with stakeholders at all levels.
Preferred Background & Experience:
- Quality certification (e.g., CQE, CQA) is highly desirable.
#LI-ES1 #LI-onsite
Below is the base pay range for this full-time position. The actual base pay will depend on several factors unique to each candidate, including one’s skills, qualifications, and experience. At 10x, base pay is also just one component of the Company’s total compensation package. This role is also eligible for 10x’s equity grants, its comprehensive health and retirement benefit programs, and its annual bonus program or sales incentive program. During the hiring process, your 10x recruiter can share more about the Company’s total compensation package.
Pay Range
About 10x Genomics
At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world.
We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools have enabled fundamental discoveries across biology including cancer, immunology, and neuroscience.
Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference.
Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation, or any other characteristic protected by applicable law.
10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.
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