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The Sr. Quality Assurance Engineer role provides advanced quality engineering support by leading complex validation, risk management, and change control activities. It ensures regulatory and internal compliance while driving continuous improvement across product development, operations, and supplier management. The position acts as a key technical resource and mentor, promoting quality system harmonization and operational excellence across multiple sites.
Job Responsibility:
Lead and execute advanced quality engineering activities including process validation, risk assessments, and supplier quality improvements
Oversee CAPAs, complaints, and audit follow-up activities ensuring timely and effective resolution
Conduct internal and supplier audits, driving corrective actions and continuous improvement initiatives
Provide quality oversight of EQMS documentation to ensure alignment with global standards (21 CFR 820, ISO 13485, EU IVDR)
Mentor junior engineers and technicians on quality system requirements and best practices
Collaborate cross-functionally to evaluate data trends, identify risks, and implement process enhancements across operations
Requirements:
Bachelor’s Degree in a science or technical field
or Associate’s Degree and 2 years of relevant experience
or High School Diploma or General Education Degree (GED) and 4 years of relevant experience
5 years of relevant job-related experience
Demonstrated ability to perform the essential duties of the position with or without accommodation
fluency in English and communicate effectively in both written and verbal form
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis