Senior Software Quality Engineer
Job no: 616107
Work type: Permanent
Location: Gothenburg, Mechelen
Categories: Engineering, Quality & Regulatory, Western Europe, Individual Contributor
Cochlear is the global market leader in implant hearing solutions and is a top 50 company on the ASX. Cochlear's mission is to help people Hear and Be Heard.
Our Quality Department is currently looking for a Senior Software Quality Engineer on a permanent basis based in our location in Mechelen (Belgium) or Gothenburg (Sweden).
The Senior Software Quality Engineer provides assurance that Software/Firmware projects are conducted in accordance with approved procedures and regulatory standards, and that the product developed satisfies customer needs but also identify and implement improvements that will ensure Cochlear continues to produce compliant products that satisfy customer, regulatory and business requirements, more effectively.
The Senior Software Quality Engineer supports the Software/Firmware teams and ensure they follow approved processes for creating Software Requirement Specifications, Software Design Specifications, software architectures, traceability analysis, risk analysis, design reviews, software code reviews, software verification & validation documentation and maintaining software anomalies.
- Support the Research & Development Software design projects to ensure compliance to Quality Management System
- Collaborate with key stakeholders, ensure the completion of validation projects and documentation within established time frames to meet company objectives and goals
- Collect process monitoring data and acceptance activity data
- Plan, conduct and complete reports for Internal and Supplier Audits
- Ensure that non-conformances and CAPAs are resolved quickly and appropriately and identify, initiate and implement improvements to QMS processes and procedures
- Follow relevant quality procedures in order to deliver quality products and services and identify and support the implementation of continuous improvement
- Undertake additional quality responsibilities (e.g. audit) when appropriately trained to undertake these responsibilities
- Responsible for working with team members throughout the entire Software Development Life Cycle (SDLC) to ensure compliant implementation of medical device software
- Engineering or computer science degree (electrical / computer engineering or software discipline preferred)
- + 5-years experience working in a technical role in a medical device company - Quality, Design, Production or Project Engineer
- Experience in software development methodologies such as Agile and Scrum
- Experience with IEC 62304, 82304, 62366 and ISO 14971 standard
- Knowledge of Part 11 compliance
- Knowledge of EU MDR
- Knowledge of ISO9001/ISO13485 (FDA QSR and cGMP knowledge an advantage)
- Supporting projects from inception to ongoing change management (ie. whole product life cycle)
- Identifying gaps and opportunities for improvements to QMS procedures
- Producing, and guiding others’ writing of procedural/technical documents of a high-standard
- Initiating feedback and influencing outcomes within a project area
- Working independently to influence design and process validation outcomes
- Guiding the use of a methodical approach to problem solving
- Involvement in completing Risk Analysis - assessing mitigations, reviewing consistency of approach and application of ratings
- Conducting Audits against regulation (internal or supplier)
- Training others in small groups and in one-to-one situations
- Explaining activities / project documentation within a Regulatory audit
- Language: excellent oral and written communication skills in English (and Dutch ideally)
Developmental value of this role
This is a fantastic opportunity to gain experience in a range of developmental projects, from small and fast projects to large and long-term development projects, as well as continuous maintenance activities. You will improve your influencing skills through cross functional working groups, supporting projects in hardware (ASIC, mechanical) and contribute to the Quality and Regulatory strategic direction toward consistency, standardisation and compliance.
This is your chance to be part of a premier organization with a great culture, working in a dynamic, growing and rapidly evolving environment to deliver outstanding results that benefit our customers every day. Be part of something purposeful and APPLY now by clicking on the link below and see your career grow!
Due of summer holiday period, the Talent Acquisition process can have some delay. Thank you for your understanding.
Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing 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. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always. Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).
Cochlear is committed to providing equal opportunities to avoid unlawful discrimination on the grounds of race, sex, disability, sexual orientation, religion/belief or age. In line with our corporate ethics and statutory obligations we strive to ensure that the work environment is free of harassment and bullying and that everyone is treated with dignity and respect - this is an important aspect of ensuring equal opportunities in employment.
Advertised: W. Europe Daylight Time
Anticipated Application Closing:
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