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Senior Design Quality Engineer

Medartis develops, manufactures and distributes titanium screws and plates, surgical instruments and system solutions for fracture fixation. We place the highest priority on maintaining stringent quality standards, continuous further development and innovation as well as comprehensive service provision for physicians, staff and patients.

The Senior Design Quality Engineer leads the Quality project teams by reviewing prints, risk assessments and quality planning. This includes communication with Engineering on inspection methods, materials and suppliers.

Your responsibilities

  • Develops quality objectives for project team.
  • Develops quality plans, risk assessment with Engineering project team.
  • Contribute to the Engineering design review meeting, including reviewing and signing phase documents.
  • Follow and assure that personnel comply with FDA Quality Systems Regulation, ISO Standards and SOP’s as defined by Medartis’ policies, practices and procedures.
  • Independently inspect components and finished goods for compliance to specifications.
  • Apply quality-engineering techniques on new and/ or existing products.  Assure all products meet or exceed customer requirements.
  • Work with suppliers to resolve non-conforming issues or other matters related to supplier corrective actions, material review board and/or CAPAs.
  • Ensure that all record keeping and documentation is completed in a timely manner according to established policies, practices and procedures.
  • Continuously review methods, procedures, processes, etc. to determine improvements related to quality and cost to increase efficiencies.  Make recommendations and, upon approval, implement. 
  • Review changes to products in production for reliability impact to aid in the correction process, design or material problems.

Your qualifications

  • 5-10 years’ experience in Quality Engineering or Supplier Quality.
  • BS in Engineering or related field or equivalent in experience and training.
  • In-depth knowledge of quality system and ISO requirements
  • Knowledge of basic statistical and engineering principals is essential.

What we offer

This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company. We look forward to receiving your complete application.
For further information please visit our Website www.medartis.com.

We look forward to receiving your complete online application.
Medartis
Human Resources
T +1 610 961 6101
www.medartis.com
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Header

Senior Design Quality Engineer

Medartis develops, manufactures and distributes titanium screws and plates, surgical instruments and system solutions for fracture fixation. We place the highest priority on maintaining stringent quality standards, continuous further development and innovation as well as comprehensive service provision for physicians, staff and patients.

The Senior Design Quality Engineer leads the Quality project teams by reviewing prints, risk assessments and quality planning. This includes communication with Engineering on inspection methods, materials and suppliers.
  • Develops quality objectives for project team.
  • Develops quality plans, risk assessment with Engineering project team.
  • Contribute to the Engineering design review meeting, including reviewing and signing phase documents.
  • Follow and assure that personnel comply with FDA Quality Systems Regulation, ISO Standards and SOP’s as defined by Medartis’ policies, practices and procedures.
  • Independently inspect components and finished goods for compliance to specifications.
  • Apply quality-engineering techniques on new and/ or existing products.  Assure all products meet or exceed customer requirements.
  • Work with suppliers to resolve non-conforming issues or other matters related to supplier corrective actions, material review board and/or CAPAs.
  • Ensure that all record keeping and documentation is completed in a timely manner according to established policies, practices and procedures.
  • Continuously review methods, procedures, processes, etc. to determine improvements related to quality and cost to increase efficiencies.  Make recommendations and, upon approval, implement. 
  • Review changes to products in production for reliability impact to aid in the correction process, design or material problems.
  • 5-10 years’ experience in Quality Engineering or Supplier Quality.
  • BS in Engineering or related field or equivalent in experience and training.
  • In-depth knowledge of quality system and ISO requirements
  • Knowledge of basic statistical and engineering principals is essential.
This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company. We look forward to receiving your complete application.
For further information please visit our Website www.medartis.com.

We look forward to receiving your complete online application.
Medartis
Human Resources
T +1 610 961 6101
www.medartis.com
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