Senior QA Engineer - Hybrid CAPA & Quality Lead

Comrise

Redmond

Hybrid

AUD 90,000 - 120,000

Full time

22 hours ago
Be an early applicant

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Comrise is seeking an experienced Senior Quality Assurance Engineer to support manufacturing operations and supplier quality in a fast-paced, regulated environment. You will investigate nonconformances, manage CAPAs, perform root cause analysis, and drive continuous improvement initiatives.

The role requires independent handling of multiple quality issues, leadership in cross-functional discussions, and collaboration with suppliers to resolve manufacturing and supplier quality challenges.

Qualifications

  • Bachelor’s degree in Engineering or related science discipline.
  • Minimum 3 years of quality engineering/QA in manufacturing or regulated environment.
  • Strong root cause analysis and CAPA experience.

Responsibilities

  • Own and manage NC and CAPA records; ensure timely investigation and closure in TrackWise.
  • Lead root cause investigations and coordinate corrective actions with cross-functional teams and suppliers.
  • Dispostion nonconforming products through MRB process.
  • Support manufacturing-related complaint investigations and product field actions.
  • Lead containment activities during production disruptions or line-down situations.
  • Coordinate with suppliers on quality issues and SCARs; review SICRs and PPAP activities.
  • Maintain quality performance metrics and KPIs; drive continuous improvement.

Skills

Root cause analysis
Cross-functional collaboration
Quality system knowledge
Analytical thinking
Communication skills

Education

Bachelor's degree in Engineering

Tools

TrackWise
MasterControl
SAP
PPAP
SCAR
DFMEA

Job description

Comrise is seeking an experienced Senior Quality Assurance Engineer to support manufacturing operations and supplier quality in a fast-paced, regulated environment. You will investigate nonconformances, manage CAPAs, perform root cause analysis, and drive continuous improvement initiatives.

The role requires independent handling of multiple quality issues, leadership in cross-functional discussions, and collaboration with suppliers to resolve manufacturing and supplier quality challenges.

Get your free, confidential resume review.

or drag and drop your file here.

Similar jobs

Similar jobs worth comparing

Senior Quality Engineer - MedTech CAPA & RCA Lead
Senior Quality Engineer - MedTech CAPA & RCA Lead

GForce Life Sciences • Redmond

On-site
AUD 90,000 - 120,000
Senior QA Engineer - Medical Devices | CAPA & NC
Senior QA Engineer - Medical Devices | CAPA & NC

Ledgent Technology • Redmond

On-site
AUD 128,000 - 140,000
CAPA & Quality Systems Lead - Hybrid (Redmond)
CAPA & Quality Systems Lead - Hybrid (Redmond)

Stryker • Redmond

Hybrid
AUD 119,000 - 198,000
Hybrid work model
Health benefits
Quality Engineer, Medical Devices - CAPA & Compliance
Quality Engineer, Medical Devices - CAPA & Compliance

Applied Medical Technology • Katherine

On-site
AUD 90,000 - 130,000
Senior Quality Assurance Engineer
Senior Quality Assurance Engineer

Comrise • Redmond

Hybrid
AUD 90,000 - 120,000
Senior Quality Assurance Engineer
Senior Quality Assurance Engineer

GForce Life Sciences • Redmond

On-site
AUD 90,000 - 120,000
Sr. Quality Engineer (CAPA/NC)
Sr. Quality Engineer (CAPA/NC)

Ledgent Technology • Redmond

On-site
AUD 128,000 - 140,000
Senior QA Engineer - Hybrid with Automation Lead
Senior QA Engineer - Hybrid with Automation Lead

Cadence Connect • Brisbane

Hybrid
AUD 120,000 - 150,000
Test Engineer – Equipment Validation (IQ/PQ) | Flexible Hours
Test Engineer – Equipment Validation (IQ/PQ) | Flexible Hours

Comrise • Redmond

On-site
AUD 80,000 - 120,000
Quality & Product Compliance Leader
Quality & Product Compliance Leader

Pacific Talent Partners Pty Ltd. • Sydney

On-site
AUD 120,000 - 180,000
Top locations