About the role
10x Genomics was founded to deliver powerful and reliable tools that fuel key scientific discoveries and drive exponential progress in our mastery of biology to advance human health. Our talented team has a distinguished record of creating innovative instruments, reagents, and software that analyze biological systems at a resolution that matches the complexity of biology.
Currently ISO 9001 certified, we are actively working towards ISO 13485 certification to further enhance our quality management systems. We are seeking a dedicated and experienced Document Control Manager to join our team. This role is critical in managing and maintaining our Quality Management System (QMS) documentation, ensuring compliance, and supporting overall quality objectives.
The Document Control Manager will oversee all aspects of document management, including the creation, review, approval, distribution, and archiving of quality documents. This role demands meticulous attention to detail and the ability to manage documentation processes efficiently to meet ISO 13485 standards without adding unnecessary bureaucracy to RUO products. A flexible and adaptive leader and highly driven self-starter with good communication skills, collaborative attitude, resilient mindset and optimistic outlook will be the happiest here.
What you will be doing:
- Establish and maintain an effective document control system to manage the lifecycle of quality documentation.
- Ensure that all documents are reviewed, approved, and distributed in a timely manner.
- Control the distribution of documents to ensure access to the most current versions in PLM.
- Ensure that the document management processes comply with ISO 9001, ISO 13485, and other relevant regulatory requirements.
- Conduct regular audits of the documentation system to verify compliance.
- Coordinate the creation, revision, and approval of SOPs, work instructions, quality manuals, forms, and other documents.
- Collaborate with cross-functional teams to ensure documents adequately reflect current processes and standards.
- Provide training and guidance to employees on document control procedures and QMS requirements.
- Support all departments in understanding and implementing document control requirements.
- Identify opportunities for improvement in document control processes and implement changes to enhance efficiency and compliance.
- Lead initiatives to optimize document control systems and software tools.
- Contributes to advance change management, PLM, ERP systems and processes.
- Develop and manage document archiving processes to ensure secure and accessible storage of records.
- Maintain and follow document retention schedules according to relevant requirements.
Minimum Requirements:
- Bachelor’s degree in Life Sciences, Engineering, or a related field.
- Minimum of 5 years of experience in document control in the life sciences or medical device industry.
- Experience with ISO 13485 documentation requirements is strongly preferred.
- Comprehensive understanding of document control principles and QMS requirements.
- Excellent organizational and time management skills.
- Strong attention to detail and ability to handle large volumes of documentation.
- Proficiency in document management software, Microsoft Office Suite (Word, Excel, PowerPoint), Google Docs (Docs, Sheets, Slides).
- Exceptional communication and interpersonal skills.
- Strong technical writing skills are a plus.
- Knowledge of GD&T & awareness of manufacturing best practices are a plus.
Preferred Skills & Attributes:
- Ability to work independently and as part of a team.
- Proactive and able to identify and solve problems effectively.
- Curious to learn and try new things and develop new skills.
- High level of integrity and professionalism.
#LI-MH1 #on-site #10xqualityjobs
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.
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.
