Manager, Quality Engineer

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. 

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

*MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
 
Summary:
 
We are seeking a dedicated and detail-oriented Quality Engineer with expertise in packaging and labeling. The ideal candidate will be responsible for ensuring that all packaging and labeling processes meet regulatory standards and company quality expectations. This role involves close collaboration with cross-functional teams, including manufacturing, R&D, and regulatory affairs, to maintain and improve product quality.
Essential Functions:

• Develop, implement, and maintain quality procedures for packaging and labeling.
• Conduct regular inspections and audits of packaging and labeling processes.
• Ensure compliance with industry standards, regulatory requirements, and company policies.

Process Improvement:

• Identify and analyze packaging and labeling process inefficiencies and implement corrective actions.
• Lead continuous improvement initiatives to enhance product quality and operational efficiency.
• Collaborate with production teams to resolve quality issues and implement best practices.

Documentation & Reporting:

• Maintain comprehensive documentation of quality processes, inspections, and audits.
• Prepare detailed reports on quality metrics, trends, and corrective actions.
• Ensure all packaging and labeling documentation complies with regulatory standards.

Regulatory Compliance:

• Stay updated on current regulations and standards related to packaging and labeling in the industry.
• Ensure that all packaging and labeling activities comply with relevant regulations such as FDA, ISO, and other applicable standards.

Training & Development:

• Train and mentor production staff on quality standards and procedures.
• Develop training materials and conduct regular training sessions on packaging and labeling quality.

Cross-Functional Collaboration:

• Work closely with R&D, manufacturing, and regulatory teams to support new product development and launches.
• Participate in design reviews and provide input on the packaging and labeling requirements.

Requirements:

• Bachelor’s degree in quality, mechanical or industrial engineering, Quality Management, or related field.
• Minimum of 3-5 years of experience in quality engineering with a focus on packaging and labeling.
• Strong knowledge of quality control principles, methodologies, and tools.
• Familiarity with regulatory standards such as FDA, ISO, and GMP.
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills.
• Ability to work effectively in a team environment and manage multiple projects simultaneously.
• Proficiency in quality management software and Microsoft Office Suite.
• Six Sigma or Lean Manufacturing certification.
• Experience in the medical device or pharmaceutical industry.
• Knowledge of statistical analysis software (e.g., Minitab).

Reports to: Director, Quality Assurance Combination Products
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $155,000 - $166,000