Senior QA Engineer (Manufacturing)
Core
Provide technical leadership in manufacturing quality, ensuring products are developed and produced with highest standards of quality, compliance, and operational performance.
Role type
Senior IC manufacturing quality engineer
Builds
Manufacturing quality strategies, readiness plans, preventive control mechanisms, and digital quality systems
Domain
Medical device manufacturing / Quality Engineering
Required skills
Risk-based quality planning, process validation, control strategy development, manufacturing readiness assessments, data analysis for systemic risk reduction, regulatory compliance, technical leadership, cross-functional collaboration
Preferred skills
Medical device industry background, MES/digital quality systems, automation, advanced analytics, Computer Software Assurance (CSA), Quality by Design, AI tools application
Technologies
MES, digital quality systems, automation, advanced analytics, AI tools
Responsibilities
Lead complex Quality Engineering activities for new products and manufacturing capability introductions; Drive risk-based quality planning and validation activities; Deploy and enhance Manufacturing QA standards and methodologies; Analyze manufacturing data to identify systemic risks and improve Right First Time performance; Support quality activities for automation and digital quality systems; Develop and implement manufacturing quality strategies; Provide technical leadership through coaching and mentoring; Partner with cross-functional teams to influence design decisions; Participate in governance forums and drive resolution of compliance issues; Support internal, external, and supplier audits.
Seniority
Senior, hands-on IC with strategic influence
