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June

Quality Manager

Cochlear Ltd - Sydney, NSW

Manufacturing & Industrial
Source: uWorkin

JOB DESCRIPTION

Quality Manager


Job no: 613036
Work type: Permanent
Location: Sydney
Categories: Quality & Regulatory, Oceania, People Manager

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. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It’s an incredible piece of engineering and the only product in the world that restores a sense through technology.

We are looking for a Quality Manager to lead and manage the Sydney sites Quality Operations teams to ensure that products are manufactured in conformance with specifications and regulatory requirements and meet all release requirements before delivery to customers

This is a permanent full-time role based in our global headquarters in Macquarie University.

Key Responsibilities:

  • Partner with the global quality operations team in the development of an effective quality management system and review approach across manufacturing sites to ensure regulatory compliance and continued certification.
  • Develop and introduce appropriate quality controls to ensure product and process quality is predictable and
  • Provide direct support for external regulatory audits and inspections, and ensure the site is in a constant state of “audit readiness”.
  • Where non-conformance occurs, ensure effective root cause and corrective action is taken based on risk
  • Ensure all quality operational processes are compliant to applicable regulations (ISO 13485, 21 CFR Part 820), and meet the flexible needs of the business.
  • Identify and implement effective operational quality measures and metrics, to drive achievement of Quality Objectives. Ensure robust reporting of quality data is available (as input to MQRM, Management Review)
  • Produce key performance metrics and data analysis.
  • Attract, develop, and retain the best team to deliver Cochlear’s current and future business objectives

Key Requirements

Minimum:

  • Degree level education (preferably engineering or science)
  • Strong and proven experience in medical device manufacturing environment
  • Evidence of the application of risk management skills in manufacturing
  • Strong knowledge of ISO 13485 and FDA 21CFR Part 820
  • Project management experience and people/task management experience
  • Ability to work cross-functionally
  • Strong communication and influencing skills

Ideal:

  • Accredited lead auditor
  • Knowledge of continuous improvement methodology and process control techniques an advantage
  • Experience in the application and use of statistical process controls
  • Experience as a manager of experienced quality professionals in a manufacturing environment

Key Benefits:

  • Broad cross functional work – increase influencing, networking and facilitation skills
  • Leadership – drive the development of a high performing team of quality professionals
  • On-site undercover parking
  • Flexible working environment

Cochlear will offer you the opportunity to continuously improve your skills in a globally active high-tech manufacturing environment. 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. Take the first step towards a career you can be proud of. Apply online today.

Advertised: 11 Jun 2021 AUS Eastern Standard Time
Anticpated Application Closing: 11 Jun 2021 AUS Eastern Standard Time

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