Responsibilities• Accountable for ensuring full quality and regulatory compliance for his/ her unit(s) • Taking charge and participate in multidisciplinary improvement, • Proactively participate in daily direction of his/ her units like MRB (Material Review Board), escalations (production stop), PPG’s, supplier meetings, daily commcell, • Maintaining and improving performance via Quality tools and techniques, • Ensures site audit readiness and hosts the quality system audits, • Performs internal audits in the units on applicable procedures, regulations and instructions, • Proposes corrective measures for the audit findings and follows progress, • Stimulates and implements tools e.g. pareto, risk analysis, 5W/ 2H, Ishikawa, FMEA, 8D, PPA, • DMAIC, problem solving methods, statistical process control, 5S + 1, • Process, validate and close QN’s (Quality Notifications) in SAP and NC (Non Conformity) documents, • Reviews and approves DHR (Design History Record) before final release, • Reviews and approves DMR (Device Master Record) and DHF (Design History File) before release, • Supports timely and correct closure of CAPA’s and ensures compliancy in his unit, • Monitoring Quality of incoming goods, and the improvement of those goods. • Adhere to company procedures and maintain compliance with FDA QSR regulations and ISO 13485:2016 standards. • Perform other quality related duties as assigned. • Providing support ensuring external audit readiness and during external audits/inspections • Defines, establishes, monitors and improves training on internal auditing
Requirements• HBO level (mechanics or electronics), • 4+ years within quality assurance or quality control within an operational environment (preferably medical devices, automotive or aerospace), • Knowledge of tools e.g. pareto, risk analysis, 5W/ 2H, Ishikawa, FMEA, 8D, problem solving methods, statistical process control, 5S + 1, PPA or APQP, DMAIC, • Process minded and able to make and optimize procedures and supporting documents, • Excellent analytical, problem solving and root-cause analysis skills • Ability to present issues to a management level, • Excellent communication and reporting skills in Dutch and English. • Character: people-oriented, no-nonsense, pro-active, make-it-happen mentality, pressure-resistant, able to get things done from people, disciplined.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rowin van der Zwaan.