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Quality Engineer

Apply now Job no: 607212
Work type: Permanent
Location: Gothenburg
Categories: Western Europe, Individual Contributor, Engineering, Quality & Regulatory

Change people’s lives and love what you do!  Cochlear develops world-leading medical devices that help people hear. As the top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.

This is a fantastic opportunity for an experienced Quality Engineer to work in our quality and resource department in Gothenburg. You will be joining a global company with a team of passionate colleagues to help develop Cochlear’s quality system to ensure maximum security and regulatory compliance. You will have the prospect of working cross functionally to influence the organisation regarding processes, system development and improvements locally and internationally.

Key Responsibilities

The purpose of the Quality Engineer role is to be responsible for effectuating the Q&R Ownership of CBAS CAPA program and internal audit program. In order to be successful candidate for the role, you need to have the willingness to assist in the continual improvement and development of quality systems.

In this role you will be responsible for:

  • acting and leading as the CAPA program coordinator which include reviewing the CAPA plan and leading CAPA Review Board
  • acting as deputy for Lead NC coordinator within non-conformities
  • leading the internal audit program at CBAS by acting as audit program coordinator
  • ensuring strong quality systems and process management thru development of trending reports and actively participating in development of Quality Procedures
  • provision of intelligence about best practice for quality strategies

 

You will have the benefit of working across multiple interesting and innovative projects, with significant career development avenues for the right person. Cochlear offers a supportive and collaborative working environment with ample opportunity to progress.

Key Requirements

  • Education within the field of engineering and/or science or other relevant areas
  • Excelling knowledge of ISO 13485 Medical Devices and FDA Quality System Regulation 21 CFR Part 820 for regulatory purposes.
  • Prior experience of quality systems for medical device companies  
  • Internal auditor qualification
  • Strong written and verbal English skills
  • Ideally have knowledge of FDA Quality System Regulation 21 CFR Part 11 and Knowledge of ISO 14971 – Medical Device – Application of risk management to medical devices

Cochlear’s global mission is to help people hear and be heard. Cochlear BAS is the division of Cochlear that designs and manufactures the world’s leading bone conduction and other implantable acoustic solutions. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Situated in Mölnlycke, 10 minutes from the city centre of Gothenburg, Sweden, the head office employs approximately 200 people whose responsibilities include research, product design and development, marketing, quality and regulatory, manufacturing, distribution and administration for our implantable acoustic products

Advertised: W. Europe Daylight Time
Applications close: W. Europe Daylight Time

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