Job no: 609042
Work type: Permanent
Categories: Oceania, Individual Contributor, Quality & Regulatory
- Friendly, fun, supportive and collaborative team
- Global branded ASX listed double digit growth company
- A global leader in medical devices & hearing loss technologies
Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. We are seeking a Corrective Action, Preventative Action Specialist to join our Quality team to drive CAPA process activities that ensure timely and effective resolution of known and potential quality issues. You will ideally have a background in the pharma or medical devices industry and are results focussed.
As part of a small collaborative and collegiate team you will be responsible for the following activities.
- Consultation with CAPA owners to ensure CAPA documentation is thorough, compliant, and completed to a high standard
- Maintain tracking for CAPA documents - requests, investigation, implementation, and effectiveness monitoring so that CAPAs are completed in a timely manner commensurate to risk
- Maintain CAPA program administration compliance including updates to the register, completion of CAPA requests, and obtaining signatures on CAPA documents
- Develop and improve processes with programs such as Complaints, NCR, Internal Audits, Device Analysis, and Service & Repair to create robust interfaces and escalation paths
Why is this role right for you?
- You are degree qualified and have experience in understanding newly presented information quite quickly
- Knowledge and experience of Quality Management Systems and an understanding of ISO 9001 requirements with ISO13485
- You are results focused and consistently achieves goals and able to flex and adapt plans to changing circumstances
- You are an effective communicator and can clearly and concisely express your opinions in writing, avoiding conjecture
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!
Be rewarded for your performance and participate in our benefits which you can tailor to suit your individual needs. These include; Flexible work arrangements, Employee support services, Salary continuance insurance, Cochlear Day and Cochlear Advantage employee discount program.
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™).
Advertised: AUS Eastern Daylight Time
Applications close: AUS Eastern Daylight Time
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