Senior Quality Engineer (P-4555)

We are seeking a Senior Quality Engineer to join our team and drive excellence in both product quality and supplier quality. In this role, you will play a pivotal role in ensuring the highest standards of quality throughout our product life cycle and supplier interactions. You will be responsible for developing, implementing, and maintaining quality systems and processes that comply with regulatory requirements and industry best practices. The role will involve close collaboration with cross-functional teams, including R&D, manufacturing, supply chain, and regulatory affairs, to ensure the consistent delivery of safe and effective products to our customers.

What you will be doing:

• Product Quality Management:
  • Develop, implement, and monitor quality plans, policies, and procedures to ensure product quality and compliance with regulatory standards (e.g., FDA, ISO, GMP).
  • Lead root cause analysis and corrective/preventive actions (CAPA) to resolve product quality issues and improve processes.
  • Conduct risk assessments and implement risk mitigation strategies to ensure product safety and efficacy.
  • Oversee validation and verification activities for new products and processes.
  • Manage internal and external audits to ensure compliance with quality standards and regulatory requirements.
  • Provide quality guidance and support to cross-functional teams during product development and manufacturing.
• Supplier Quality Management:
  • Develop and maintain supplier quality management programs to ensure the selection and qualification of suppliers meet company and regulatory requirements.
  • Conduct supplier audits and assessments to evaluate their quality systems, processes, and capabilities.
  • Establish and maintain strong relationships with suppliers, fostering a culture of continuous improvement and collaboration.
  • Monitor supplier performance through metrics and key performance indicators (KPIs), driving improvements where necessary.
  • Manage supplier-related non-conformances, including root cause analysis, corrective actions, and ongoing monitoring.
  • Collaborate with the supply chain and procurement teams to ensure the consistent delivery of high-quality materials and components.
• Continuous Improvement:
  • Lead and participate in quality improvement initiatives and projects aimed at enhancing product quality, reducing defects, and optimizing processes.
  • Apply statistical techniques and quality tools (e.g., Six Sigma, Lean) to analyze data, identify trends, and drive data-driven decision-making.
  • Provide training and mentorship to junior quality engineers and other staff to build a culture of quality excellence within the organization.

Minimum Qualifications:

• Bachelor's or Master's degree in a relevant scientific or engineering discipline (e.g., Mechanical/Biomechanical Engineering, Biology, Biochemistry).
• 7 years of experience in quality engineering, with a focus on supplier and product quality
• In-depth knowledge of regulatory requirements and industry standards (e.g., FDA, ISO 13485, GMP).
• Proven experience in conducting audits, managing CAPA, and implementing quality systems and processes.
• Strong analytical and problem-solving skills, with a track record of driving quality improvements and operational excellence.
• Strong communication and interpersonal skills, with the ability to influence and collaborate with stakeholders at all levels.

Preferred Background and Experience:

• Relevant experience in the life science industry.
• Quality certification (e.g., CQE, CQA) is highly desirable.

#LI-ES1 #LI-onsite