Senior Quality Assurance Engineer (Defined Term)
Core
Senior Quality Assurance Engineer leading quality engineering initiatives, process controls, and CAPA systems for the distribution supply chain in the medical device industry.
Role type
Senior Quality Assurance Engineer (Supply Chain)
Builds
Distribution supply chain operations and product qualification processes
Domain
Medical Device / Healthcare / Supply Chain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality engineering methodologies, Lean, Six Sigma, root cause analysis, structured problem-solving, SOP review, risk management, cross-functional collaboration
Preferred skills
SAP ERP, Manhattan systems, packaging requirements, supplier quality experience
Technologies
SAP ERP, Manhattan systems
Responsibilities
Champion departmental and cross-functional engineering initiatives; Provide project direction, coaching, and mentoring for engineering and technical team members; Serve as a technical mentor for identifying and resolving quality issues, including nonconforming events and CAPA processing; Identify and implement effective process controls and systems to support product development and distribution; Proactively investigate, identify, and implement best-in-class quality engineering practices; Lead the implementation of quality assurances, process controls, and CAPA systems to meet regulatory and customer requirements; Review, evaluate, and approve SOPs, work instructions, project plans, risk management files, and process verifications; Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues; Assure the development and execution of streamlined business systems that effectively identify and resolve quality issues; Collaborate cross-functionally with site operational teams and divisional partners to ensure quality compliance on assigned projects; Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures; Engage in continuous process improvement and optimization initiatives.
Seniority
Senior, hands-on IC with mentorship responsibilities