Senior Quality Engineer (Operations)

• Accountable for ensuring full quality and regulatory compliance for his/ her units (Building Blocks).

• Taking charge and participate in multidisciplinary (DMAIC) 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 Fil) before release.

• Supports timely and correct closure of CAPA’s and ensures compliancy in his/ her units.

• Monitoring Quality of incoming goods, and the improvement of those goods.

• Adhere to company procedures and maintain compliance with FDA QSR regulations, ISO 13485 and other applicable standards.

• Perform other quality related duties as assigned.

Skills and competencies:

• 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, DMAIC/ PDCA.

• 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.

Interesse?
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