QA Engineer II (P-4606)

We are seeking a highly experienced and motivated QA Engineer II 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
• 2 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.

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