Quality Engineer: Supplier & Process Excellence

Actalent; Redmond; On-site; AUD 126,000 - 139,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

PTO / Leave

Job summary

Actalent in Redmond, WA is seeking a Quality Engineer to ensure product and process quality in a live manufacturing environment. The role involves managing NCs and CAPAs, supporting supplier quality, and driving changes and validations across the plant.

You will collaborate with operations, engineering, quality, and regulatory teams, lead problem solving, PPAP activities, and maintain quality system documentation using TrackWise, MasterControl, and SAP.

Qualifications

• Engineering or science degree or equivalent technical education.
• Experience in medical devices or regulated industry.
• Experience on production floor and cross-functional teams.

Responsibilities

• Work closely with Operations and other business functions to ensure the quality performance of products and processes.
• Collaborate with internal cross-functional teams and suppliers to address top quality issues and drive effective resolutions.
• Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventive Action (CAPA) records, ensuring timely processing and closure within the electronic quality management system (e.g., TrackWise).
• Support the execution and analysis of manufacturing-related complaint investigations and product field actions, ensuring robust documentation and follow-up.
• Investigate internal non-conforming product within the MRB process and issue NCs as appropriate, including disposition of non-conforming materials.
• Communicate and collaborate with suppliers regarding non-conformances and elevate SCARs as requested.
• Execute and manage SICRs, engaging cross-functional teams for technical assessment, risk evaluation, and approval.
• Support manufacturing transfers to and from other plants or facilities by executing appropriate quality activities.
• Collaborate with stakeholders to identify and implement opportunities for supplier part certification to improve incoming quality and efficiency.
• Engage in the development and improvement of internal manufacturing and distribution processes for existing products, focusing on quality, robustness, and efficiency.
• Perform PPAP activities for supplier or internal changes; participate in review of procedures related to quality and supplier management.
• Support development and review of process and equipment validation and MSA activities; maintain documented quality systems.
• Maintain KPIs for process and product quality, perform data analysis, interpret trends, and implement corrective actions.

Skills

Root cause analysis

CAPA management

Supplier quality

Change management

Process validation

PPAP

MSA

Documentation control

Regulatory awareness

Education

Engineering or science degree

Tools

TrackWise

MasterControl

SAP

ERP systems

Job description

Actalent in Redmond, WA is seeking a Quality Engineer to ensure product and process quality in a live manufacturing environment. The role involves managing NCs and CAPAs, supporting supplier quality, and driving changes and validations across the plant.

You will collaborate with operations, engineering, quality, and regulatory teams, lead problem solving, PPAP activities, and maintain quality system documentation using TrackWise, MasterControl, and SAP.