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04.10.2016

Senior Quality Engineer

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.

Large Manufacturing Medical Devices company.

ROLE DESCRIPTION

Monitor and drive quality and compliance in his/her unit to improve product - and process quality, reduce cost-of non-quality
and improve lean 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.

RESPONSIBILITIES

- Operational units: unit engineer, procurement, unit manager, shop floor controller, engineers and operators.
- Supplier quality engineers: trigger to SQE for starting supplier 8D steps, provide SQE with input for SCAR (supplier corrective actions request) towards SQE in case of structural problems with a supplier.
- Development: LCM (Life Cycle Management), PPG and project teams.
- Manufacturing engineering.
- Reject handlers.
- Key markets, field service engineers, global customer service.

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, 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.

- concise and fact based,
- output orientated,
- zero-defects mindset,
- team player,
- must have desire to succeed and make a difference.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.



 
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