10x is seeking a QA engineer II to establish, maintain and improve the product quality, compliance and processes to assure compliance with company policies, international standards and applicable regulatory requirements. This position works indirectly and directly with multiple functions and global quality to assure effective implementation of quality processes and drive continuous improvements.
Individuals applying for this position must be self-starters, strategic thinkers, action driven, thrive in a fast-paced environment, excel at managing multiple priorities, succeed in communicating across the organization and with external partners, and provide immediate contribution.
What you will be doing:
- Ensure Product Compliance:Develop and maintain processes to ensure compliance with applicable regulatory requirements and ISO standards related to consumables, assays, and other products
Generate and maintain product Safety Data Sheets (SDS) in accordance with regulatory requirements
Understanding of Occupational exposure limits (OELs), Derived No-Effect Level (DNEL) and waste disposal of reagent and chemicals
- Manage Quality Operations:Investigate and resolve product quality issues, including nonconformances, deviations, and complaints related to consumables, assays, and other products
Oversee corrective and preventive actions (CAPA), risk assessments, and change control processes
- Supplier Quality Management:Conduct supplier evaluations, performance monitoring, and supplier audits
Manage material qualifications and follow up on supplier-related quality issues to ensure consistent product quality
- Other Responsibilities:Track key quality metrics and drive continuous improvements 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:
- A master’s or bachelor’s degree in biology, chemistry or science discipline, coupled with 2+ years (MS) or 5+ years (BS) of Quality Assurance experience in a manufacturing environment for Life Sciences or Pharmaceutical /Medical Device industry.
- Competent analytical and problem-solving skills
- Competent collaboration and communication skills with colleagues and external collaborators
- Proficient with data analysis tool
Preferred Skills and Experience:
- Experience with generating and maintaining product Safety Data Sheets (SDS) in accordance with regulatory requirements
- Experience with quality and statistical analysis tools (For example. Risk Analysis, FMEA, DOE, SPC, Six Sigma)
- Good understanding of Next Generation Sequencing (NGS) technology, along with proficiency in fundamental biological assays and tools, including qPCR and fragment analysis
- Hand on experience with electronic PLM, ERP, MES and enterprise Quality System tools
- Quality certification desirable (e.g. CQM, CQE, CQA, RAC)
- Experience with ISO9001 or ISO 13485 quality systems in a Quality Assurance role