Job Description

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Quality Assurance Engineer

Advertiser: Cylite Pty LtdMore jobs from this company

Job Information

Job Listing Date
26 Aug 2020
Location
Melbourne, Eastern Suburbs
Work Type
Full Time
Classification
Manufacturing, Transport & Logistics, Quality Assurance & Control

Cylite:

Cylite is an advanced technology company operating at the cutting edge of medical imaging systems for ophthalmic and related markets.  We are currently looking for a Quality Engineer to join our company, and we are especially interested in receiving applications from candidates with prior Medical Device or Optics experience.  The company is based in Notting Hill, Melbourne, adjacent to the Monash University Science and Technology Precinct, and provides a collaborative, friendly, and stimulating work environment.

 

The role has responsibilities (including but not limited to):

  • Develop a high level of personal expertise on the Cylite product designs, construction of assemblies, and all corresponding documented processes.
  • Develop QA inspections and tests and specify acceptance criteria.  Execute those QA tests on finished assemblies, review, and approve for our production records.
  • Ensure quality processes & procedures are accurate and are aligned with manufacturing needs – update as required.
  • Investigate the underlying causes of non-conformances, to ensure that components as supplied to us, or as handled by us, will meet our quality standards.
  • Lead continuous improvement initiatives within the manufacturing environment, with an especial regard to product and process quality.  Target the reduction or elimination of process variations.
  • Work closely with our production and engineering teams in analysing any issues that arise, from inventory through to the production and service of the product.
  • Raise quality issues to prevent any process which is not conforming to standard or deemed to be defective; implement corrective actions.
  • Assist with conducting internal audits and with any preparations required for external audits.
  • Implement tools for monitoring process capabilities (SPC), analyse the data generated, and report.

 

Experience and Qualifications Required:

  • Bachelor’s Degree in Engineering or the Physical Sciences.
  • Minimum 2 years experience in a quality role
  • Prior experience in a high-technology manufacturing environment, preferably in either a medical device or optics-related industry.
  • Knowledge and experience with quality management systems (ISO9001/ ISO13485/ FDA QSR 21CFR820).
  • Proficient computer skills in Microsoft Office and ERP Systems.
  • Experience in continuous improvement methods, such as Kaizens, Lean, Six Sigma, 5S, etc.
  • Excellent communication skills (written and verbal) and attention to detail.
  • Demonstrated problem solving ability.
  • A passion for precision and quality.
  • Good communication skills; can collaborate effectively with team members and give training to other production technicians.

As a medical equipment manufacturer, Cylite is a "Permitted Manufacturer" and is able to support on-site working.  The role will be primarily for on-site work at our factory in Notting Hill.

If you would like to apply, please forward an up to date copy of your resume with a covering letter highlighting the experience you consider relevant to the role.  Please also include a clear indication of your availability to attend for interview and to start work.

Applicants must be Australian citizens or permanent residents of Australia.

Cylite is an Equal Opportunity Employer and embraces diversity and inclusion.

The application form will include these questions:
  • Which of the following statements best describes your right to work in Australia?
  • How many years' experience do you have in a quality assurance (QA) role?

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