Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a 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.The Quality Engineer ensures regulatory compliance across the Quality Management System (QMS) and products by partnering with stakeholders, providing guidance and training to stakeholders to meet FDA 21 CFR Part 820 and (EN) ISO 13485 (and related standards).Key responsibilities include assisting in identifying, evaluating, containing, investigating, and applying corrections and corrective actions for Class 3 Active Implantable Medical Devices across Design & Development.The Quality Engineer will also provide ongoing support to project teams when potential quality issues are identified and identify and implement improvements that will ensure Cochlear continues to effectively produce compliant products that satisfy customer, regulatory and business requirements. In addition to this, they will also be responsible for providing Quality System & Regulatory mentoring and direction to other departments.The OpportunityCochlear has an opportunity for a 12 Month Contract as Quality Engineer based in our Mechelen Offices in Belgium. In this role, the successful Quality Engineer will ensure the quality and compliance of Cochlear products by supporting problem solving processes and acceptance, and reviewing, improving, and reporting the QMS process.Responsibilities include:Quality assurance support for HW mechanical & ASIC projects - 70%Ensure key project documentation for PIP related projects and R&T/incubation projects is appropriately reviewed and that verification and validation approaches are consistent with the business strategies, in the Quality management System (QMS) and industry best-practice.Work with stakeholders (internally and globally) to ensure the completion of the project and documentation within established timeframes to meet company objectives and goals.Ensure appropriate risk mitigations are identified and conducted at key phases during development project.Ensure that non-conformances and CAPA are resolved quickly and appropriately.Escalate where product is not of sufficient quality to be released or processes are not being appropriately applied which may result in risks to product quality.Assist the project teams to ensure the group is “audit ready” at any time.Conduct batch release for clinical trial ensuring all acceptance and product release activities is implemented, appropriate and in compliance with internal requirements.Design and process Assurance Continuous Improvement – 20%Participate in QMS Continuous Improvement ActivitiesIdentify, initiate and implement improvements to QMS processes.Review QMS documents for proposed changes.Plan, Conduct & complete report for Internal & Supplier audits.Review product related changesSupport the Supplier Quality Control activities for development suppliers (selection, quality agreement, evaluation, audits and monitoring).Training (10%)Translate Quality requirements and learning needs into an appropriate and effective training content so that all employees are well-equipped to understand each QMS process.Ensure appropriate level of training is delivered for process changes and improvements.Develop learning materials and provide training/coaching to others in these tools as required.What makes this opportunity unique?The role of Quality Engineer provides the unique opportunity to champion and drive initiatives toward the consistency, standardisation, and compliance of the Quality department’s strategic direction. This includes establishing operational networks within Cochlear and collaborating with other departments to improve QMS processes and witnessing the impact of the role in delivering the quality of Cochlear products to customers.About You. As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you will be able to demonstrate the following skills and experience:Required SkillsAwareness of regulations of QMS standards - ISO9001, ISO13485, FDA QSR.Knowledge of how to analyse processes, identify issues, including the application of problem-solving methodologies.Application of risk-based methodologies to identify solutions to issues recognised.Experience in working with multi-site projects.Experience working in a medical device company.Ability to work independently as well as in collaboration with other teams and departments.Language: excellent oral and written communication skills in EnglishTraining others in small groups and in one-to-one situationEngineering or Science degree or equivalentDesired SkillsSound organisational and interpersonal skills: including the ability to competently liaise and provide feedback to internal and external customers regarding project issues.Direct experience with implementation of improved or new QMS processes.Quality engineering experience in a (Class 3) regulated environment an advantage.Direct quality experience in non-conformance, CAPA, SPC, Internal/Supplier Audit activitiesProficient in writing procedural and technical documents.Passion for consistency, standards, accurate and complete documentation.What we offerAn attractive remuneration package and flexible extra-legal benefitsAn extensive onboarding and training programAn enjoyable work environment with attention to life-work balance and homeworkingA stimulating environment with growth opportunities and opportunity to meet multi-disciplinary colleagues across the globeThis 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!Cochlear SummaryCochlear’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™).Equal opportunitiesCochlear 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.
