Senior Quality Assurance Engineer

Comrise; Redmond; Hybrid; AUD 90,000 - 120,000; Full time

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

Work Arrangement: Hybrid – 4 days onsite, 1 day remote (remote day available after completion of training)

Position Overview

We are seeking an experienced Senior Quality Assurance Engineer to support manufacturing operations and supplier quality activities within a fast-paced, regulated manufacturing environment.

This role will play a key part in maintaining product and process quality by investigating nonconformances, managing corrective and preventive actions (CAPAs), conducting root cause analysis, and driving continuous improvement initiatives. The ideal candidate is a proactive problem-solver who can independently manage multiple quality issues, lead cross-functional discussions, and work with urgency to resolve manufacturing and supplier-related challenges.

Key Responsibilities

Quality Systems & Nonconformance Management

• Own and manage internal and supplier-related Nonconformance (NC) and Corrective and Preventive Action (CAPA) records, ensuring timely investigation, documentation, and closure within TrackWise.
• Lead root cause investigations and coordinate corrective actions with cross-functional teams and suppliers.
• Investigate and disposition nonconforming products through the Material Review Board (MRB) process.
• Support manufacturing-related complaint investigations and product field actions.
• Lead problem-solving discussions and coordinate containment activities, particularly during production disruptions or line-down situations.

Supplier Quality Management

• Partner with suppliers to investigate quality issues and drive resolution, escalating Supplier Corrective Action Requests (SCARs) when necessary.
• Review and manage Supplier Initiated Change Requests (SICRs), coordinating cross-functional assessments and approvals.
• Evaluate supplier changes and oversee Production Part Approval Process (PPAP) activities.
• Support manufacturing transfers between facilities and identify opportunities for supplier part certification.

Process Improvement & Validation

• Support continuous improvement initiatives focused on manufacturing efficiency, product quality, and production throughput.
• Review and support process and equipment validation and qualification activities, including Measurement System Analysis (MSA).
• Evaluate internal and supplier-proposed process changes and assess their potential impact on product quality.
• Review validation protocols, reports, procedures, work instructions, change orders, and other quality documentation.
• Maintain and analyze quality performance metrics and KPIs, identifying trends and implementing appropriate improvement actions.
• Participate in the development and revision of quality procedures and manufacturing processes.

Required Qualifications

• Bachelor's degree in Engineering or a related scientific discipline.
• Minimum of 3 years of quality engineering or quality assurance experience in a manufacturing or regulated environment.
• Strong experience with root cause analysis, nonconformance investigations, and corrective/preventive actions.
• Experience collaborating with cross-functional teams to resolve manufacturing and supplier quality issues.
• Ability to independently manage multiple priorities in a fast-paced, time-sensitive environment.
• Excellent communication, organizational, analytical, and problem-solving skills.

Preferred Qualifications

• Experience in the medical device industry or another highly regulated manufacturing environment.
• Manufacturing floor experience and familiarity with production operations.
• Experience with process and equipment validation, qualification, and validation documentation.
• Familiarity with PPAP, SCAR, DFMEA, PFMEA, Control Plans, and Process Flow Diagrams.
• Experience reviewing supplier changes and assessing quality and validation requirements.
• Knowledge of quality management systems and document control processes.
• Experience with TrackWise, MasterControl, and SAP.
• First shift.
• Typically 7:30 AM to 5:00–6:00 PM, with flexibility depending on business and production needs.
• Four days onsite and one remote day per week. Remote work will be available after completion of initial training.
• Frequent interaction with manufacturing operators, engineering, regulatory, compliance, and supplier teams.
• Fast-paced manufacturing environment requiring flexibility, sound judgment, and the ability to respond quickly to emerging quality issues.