Senior Quality Engineer (Operations)

Location: Eindhoven, NB, nl

Company Description

Met ambitie voor techniek, ben je bij ons aan het juiste adres. Als marktleider in het detacheren van technische expertise, werven wij voor toonaangevende bedrijven als o.a. Phillips en DAF. Ambieer jij een carrière als technisch professional? Bij ons kun je rekenen op een afwisselende loopbaan met spraakmakende projecten binnen jouw vakgebied. Of dat nu hoogspanning, windenergie of een ander thema is. Wij helpen jou met het realiseren van je ambities.

Job Description

• 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.

Qualifications

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.

Additional Information

Interesse?
Stuur een ge-update versie van je CV via mail en wij nemen zo snel mogelijk contact op met je.