Senior QA Engineer (P-4606)

Posted 11 Days Ago
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Office, Lilongwe, Central Region
5-5
Senior level
Biotech
The Role
The Senior QA Engineer will manage quality operations, resolve product issues, oversee supplier quality management, and drive continuous improvement initiatives.
Summary Generated by Built In

We are seeking a highly experienced and motivated Senior QA Engineer to join our team and lead our efforts in maintaining and enhancing both product quality and supplier quality. 

In this crucial role, you will ensure that the highest standards of quality are maintained throughout our product lifecycle and supplier interactions. You will be responsible for developing, implementing, and maintaining quality systems and processes that meet regulatory requirements and industry best practices. 

This position involves close collaboration with cross-functional teams, including R&D, Engineering, Software, Manufacturing, Supply Chain and Supplier, to ensure the consistent delivery of high-quality products to our customers.


What you will be doing:

Manage Quality Operations and Customer Complaints:

  • Investigate and resolve product quality issues, including nonconformances, deviations, and customer complaints, customer return related to instruments and other products.
  • Lead root cause analysis and implement corrective and preventive actions (CAPA) to drive process improvements and resolve quality concerns.
  • Conduct risk assessments and implement mitigation strategies to ensure product safety and compliance with regulatory requirements.
  • Review and oversee equipment and process qualification activities to verify compliance with intended use and industry standards.
  • Provide quality guidance and support to cross-functional teams during product transfer, and manufacturing.

Supplier Quality Management:

  • Develop and sustain supplier quality management programs to ensure supplier selection and qualification meet company and regulatory standards.
  • Perform supplier audits and assessments to evaluate their quality systems, processes, and capabilities.
  • Establish and maintain robust relationships with suppliers, fostering a culture of continuous improvement and collaboration.
  • Monitor supplier performance through metrics and key performance indicators (KPIs), driving enhancements as needed.
  • Collaborate with the engineering team and address supplier-related nonconformities, including conducting root cause analysis, implementing corrective actions, and ongoing monitoring.
  • Collaborate with supply chain teams to ensure the consistent delivery of high-quality materials and components.

Other Responsibilities:

  • Lead and drive in quality improvement initiatives and projects aimed at enhancing product quality, reducing defects, and optimizing processes.
  • Track key quality metrics and drive continuous improvement and preventive action programs.
  • Support internal and external audits.
  • Perform additional duties as assigned by management to support the company’s compliance and quality objectives.


Minimum Requirements:

  • Bachelor’s degree or higher in a relevant engineering discipline such as mechanical or electrical engineering
  • 5 years of experience in an instrument manufacturing environment within the Life Sciences or Medical Device industry.
  • Good knowledge of industrial standards or requirements, such as ISO 9001 and/or ISO 13485.
  • Strong analytical and problem-solving skills, with a proven record of driving quality improvements and operational excellence.
  • Demonstrated experience in conducting audits, managing CAPA, and implementing quality systems and processes.
  • Effective collaboration and communication skills with cross-functional teams at all organizational levels as well as with external collaborators.
  • Proficiency with data analysis tools.


Preferred Skills & Experience:

  • Quality certification (e.g., CQE, CQA) is highly desirable.
  • Experience with instrument contract manufacturer management will be a great advantage.


#LI-ES1 #LI-onsite

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.

   

Top Skills

Data Analysis Tools
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Iso 9001
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The Company
Pleasanton, CA
1,518 Employees
On-site Workplace
Year Founded: 2012

What We Do

Accelerating biological understanding and discovery is more than a mission for 10x Genomics. It’s a commitment. Fueled by equal parts scientific vision and determined passion, we are enabling fundamental research across the life sciences by delivering rapid innovation that allows our customers to resolve complex biology—across the fields of oncology, immunology, neuroscience, and more.
As we deliver powerful new methods for discovery, we create opportunities for scientists to address and reveal the true complexities of biology and disease. Already, our products have been adopted by researchers around the world, including 97 of the top 100 global research institutions and 19 of the top 20 global pharmaceutical companies, and have been cited in over 1,200 research papers on discoveries across the life sciences.

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