Quality Engineer

Roles & Responsibilities

• Oversee quality operations, ensuring adherence to documentation, procedures, and regulatory requirements.
• Conduct complaint investigations and assist in resolving manufacturing issues.
• Provide quality oversight for key suppliers, ensuring compliance with BD, FDA, and industry standards.
• Support supplier qualification, approvals, and lifecycle design control documentation.
• Facilitate supplier collaboration and establish initiatives to improve Supplier Quality Management Systems.
• Support field corrective actions as needed.
• Drive process improvements and risk management in supplier quality.

Experience Required

• Minimum 3 years in Quality/Supplier Quality within a manufacturing environment regulated by FDA/ISO standards.
• Strong understanding of QSR, GMPs, Design Control, and Product Risk Management.
• Experience managing contract manufacturers and various commodities (e.g., PCBAs, electronics, sheet metal, optics/lasers, cabling, chemistry, biological products).
• Proficient in process development, optimization, and troubleshooting at both product and process levels.
• Experience with supplier capability assessments, auditing, and data-driven decision-making.

Skills & Certifications

• Quality systems and compliance with FDA, ISO 13485, and risk management standards.
• Process and product improvement using Six Sigma and statistical analysis.
• Technical proficiency in SAP, Minitab, Trackwise, and statistical software.
• Strong communication, stakeholder management, and leadership skills.
• Project management, problem-solving, and critical thinking abilities.

Eligibilities & qualifications

• Bachelor’s or Master’s degree in Engineering, Biological Sciences, Chemistry, or related field.
• Professional certification (CQA, CQE, Six Sigma, etc.) is a plus.
• ISO lead auditing experience preferred.