About Us:

Culture’s mission is to simplify and accelerate bioprocess development to enable our customers to bring their biopharmaceutical products to market faster.

With a focus on upstream cell culture process development, Culture has developed a unique platform that merges products, services and data management that can be applied to mammalian, microbial and viral vector production processes. This platform enables high-throughput process development projects to be rapidly and seamlessly executed directly by our customers in their own facilities, in our service laboratories, or both, all driven by our cloud-connected web application, accessible from anywhere, for designing, managing and analyzing experiments.

At Culture, we combine our passions for biomanufacturing, engineering, and operations to build new solutions that make bioprocess development faster. We value curiosity, communication, collaboration, a customer focused mindset and a drive for results.

The Opportunity:

Culture Biosciences is seeking a detail-oriented and experienced Quality Engineer to ensure the quality and reliability of our manufacturing processes and products. The Quality Engineer will play a critical role in building quality processes and maintaining compliance with quality standards, driving continuous improvement, and collaborating with cross-functional teams to ensure our products meet customer and regulatory requirements.

Key Responsibilities:

1. Quality Assurance and Quality Control:
• Develop, implement, and maintain quality control processes and quality management system procedures in manufacturing operations.
• Monitor and analyze production processes to identify and resolve quality issues.
• Conduct root cause analyses and implement corrective and preventive actions (CAPA) to address non-conformances and product complaints..
• Manage Electronic Quality Management System (eQMS) and perform Document Control functions within the quality system.
2. Compliance and Standards:
• Ensure compliance with industry standards, regulatory requirements, and company policies (e.g., ISO 9001:2015).
• Prepare and maintain quality documentation, including inspection reports, quality plans, test records.product defect, and non-conformaning product reports.
• Lead and support internal and external audits by regulatory bodies and customers.
3. Process development and Improvement:
• Collaborate with commercial, manufacturing and engineering teams to identify opportunities and implement solutions for process optimization and waste reduction.
• Implement lean manufacturing and Six Sigma principles to improve efficiency and product quality.
• Lead initiatives to enhance production quality through training, process upgrades, and technology integration.
4. Validation, Inspection and Testing:
• Carry out commissioning (IQ/OQ/PQ) of equipment and processes.
• Develop and oversee inspection plans, perform day-to-day inspections as needed including incoming, in-process and final inspections.
• Define and develop quality criteria and testing methods for raw materials, components, and finished products.
• Utilize statistical tools to monitor and improve product quality and process performance.
5. Supplier Quality Management:
• Work with suppliers to ensure raw materials and components meet quality specifications.
• Perform supplier audits and assist in resolving supplier-related quality issues.
6. Team Collaboration:
• Provide quality guidance and training to production staff to maintain high standards.
• Collaborate with design, production, and supply chain teams to ensure seamless integration of quality into all stages of the product lifecycle.
• Collaborate with R&D, mechanical, and electrical engineering team to design for manufacturability, reliability, and quality.

Qualifications:

• Education: Bachelor’s degree in engineering (Mechanical, Mechatronics, Industrial, or related field) or equivalent experience.
• Experience: 3+ years in quality engineering within a manufacturing environment.
• Knowledge and Skills:
• Strong understanding of quality standards such as ISO 9001, ISO 13485.
• Proficiency in quality tools and techniques, such as FMEA, SPC, 8D, and root cause analysis.
• Experience with statistical analysis software and ERP systems is a plus.
• Excellent problem-solving skills and attention to detail.
• Strong communication and teamwork abilities.
• Experience in automotive, robotics, medical devices, or consumer electronics industries is preferred.
• Electronic Quality Management Systems (eQMS)

Our company values are:

• Collaborate for exceptional results
• Innovate with purpose
• Earn our customers’ business every day

Location & Schedule:

• This is an onsite position. We’re looking for someone based in the San Francisco Bay Area who is able to work in person at our office in South San Francisco at least 5 days per week.

Base Salary Range:

Culture Biosciences's compensation package includes market competitive salary, equity for all full time roles, and great benefits. Our expected salary range for this role is $70,000 to $95,000. We are hiring for multiple levels and backgrounds so final offers may vary within the range provided based on experience, expertise, and other factors.

Benefits:

• Competitive salary and equity compensation
• Medical, Dental, Vision, and Life insurance
• Medical and Dependent Care FSA (prorated based on start-date)
• 401(k) plan with company match
• Responsible Time Off (non-accrual based) policy, 11 paid company holidays and a week-long winter break
• 12 weeks of parental leave at full salary

Culture Biosciences provides equal employment opportunities to all employees and applicants. We seek to build a company that promotes inclusion and expands the diversity of our industry as a whole. We encourage people with identities underrepresented in biotech and technology to apply.