Test Engineer – Equipment Validation (IQ/PQ) | Flexible Hours

Comrise

Redmond

On-site

AUD 80,000 - 120,000

Full time

20 hours ago
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Job summary

Comrise is seeking a hands-on Test Engineer to support a production capacity expansion for a Class III medical device line. You will procure, assemble, troubleshoot and validate additional automated test stations used in production.

You will lead IQ and PQ validation, develop validation plans and reports, and work with cross-functional engineering teams in a regulated manufacturing environment. The role requires self-motivation, meticulous attention to detail, and strong organizational and

Qualifications

  • Bachelor's degree in Engineering or related technical discipline.
  • Experience in equipment validation, test engineering, or manufacturing engineering is preferred.
  • Knowledge or hands-on experience with IQ/PQ validation activities is desirable.

Responsibilities

  • Support production capacity expansion through setup and implementation of automated test stations.
  • Coordinate procurement, assembly, and installation activities for test equipment.
  • Execute IQ/PQ validation activities and develop validation plans, protocols, and reports.
  • Perform replicate validations to demonstrate equipment consistency and reliability.
  • Collaborate with test engineers and cross-functional teams to support project deliverables.
  • Monitor progress and communicate status, identifying risks or delays.
  • Ensure compliance with quality procedures and medical device standards.

Skills

IQ/PQ validation
Cross-functional collaboration
Attention to detail

Education

Bachelor's degree in Engineering

Job description

Comrise is seeking a hands-on Test Engineer to support a production capacity expansion for a Class III medical device line. You will procure, assemble, troubleshoot and validate additional automated test stations used in production.

You will lead IQ and PQ validation, develop validation plans and reports, and work with cross-functional engineering teams in a regulated manufacturing environment. The role requires self-motivation, meticulous attention to detail, and strong organizational and

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