Senior Quality Engineer
Job no: 612848
Work type: Permanent
Categories: Quality & Regulatory, Western Europe, Individual Contributor
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 department in Gothenburg. You will be joining a global company with a team of passionate colleagues to help develop Cochlear’s quality management 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.
The purpose of the Quality Engineer role is to be responsible for effectuating the Ownership of CBAS 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:
- leading the internal audit program at CBAS by acting as audit program coordinator
- perform internal audits in line with the internal audit schedule
- assist in the planning and execution of external audits by Cochlear notified bodies
- acting as deputy for Lead CAPA and NC coordinator within CAPAs and non-conformities
- contribute to maintenance and improvement activities related to document management
- ensuring strong quality systems and process management through 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.
- 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.
- Knowledge of EU MDR – Regulation (EU) 2017/745
- 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 220 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
Anticpated Application Closing: W. Europe Daylight Time
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