Quality Engineer

Job Title:

Quality Engineer

Job Description

This role focuses on ensuring the consistent quality performance of products and processes within a manufacturing environment. The Quality Engineer works closely with Operations and cross-functional business teams to manage non-conformances, drive corrective and preventive actions, support supplier quality activities, and improve internal manufacturing and distribution processes. The position involves frequent interaction with stakeholders across the organization and suppliers, with a strong emphasis on root cause analysis, documentation, validation, and continuous improvement.

Responsibilities

+ Work closely with Operations and business functions to ensure high-quality performance of products and processes across manufacturing and distribution.

+ Collaborate with internal cross-functional teams and suppliers to address top quality issues and drive effective resolutions.

+ Own 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 (Track Wise).

+ Support the execution and analysis of manufacturing-related complaint investigations and product field actions, ensuring appropriate documentation and follow-up.

+ Investigate internal non-conforming product within the Material Review Board (MRB) process and issue non-conformance records as appropriate.

+ Communicate and collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) when required.

+ Execute and manage Supplier Initiated Change Requests (SICRs), coordinating with cross-functional teams to assess and approve changes.

+ Support manufacturing transfers to and from other plants or facilities by executing appropriate quality activities and ensuring compliance with quality requirements.

+ Collaborate with stakeholders to identify and implement opportunities for supplier part certification to improve quality and efficiency.

+ Engage in the development and improvement of internal manufacturing and distribution processes for existing products, focusing on quality and reliability.

+ Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.

+ Participate in and potentially lead the creation, review, and improvement of new or revised procedures related to quality and manufacturing processes.

+ Support the development and review of process and equipment validation and qualification activities, as well as Measurement System Analysis (MSA) for internal processes.

+ Maintain key performance indicators (KPIs) for monitoring process and product quality, perform data analysis, interpret trends, and initiate appropriate actions based on findings.

+ Review and support validation protocols and reports to ensure they meet regulatory and internal quality requirements.

+ Review process and equipment validation documentation to confirm compliance and robustness of manufacturing processes.

+ Conduct label reviews and support change orders to ensure accurate and compliant product labeling and documentation.

+ Perform documentation reviews to ensure completeness, accuracy, and alignment with quality system requirements.

+ Lead discussions and influence stakeholders to align on quality issues, resolutions, and improvement initiatives.

+ Provide clear direction during quality events to help quickly resolve issues and support the resumption of production.

+ Work effectively in stressful, time-sensitive situations, maintaining focus on root cause analysis and sustainable corrective actions.

+ Perform other related duties as assigned to support the broader quality systems and operations.

Essential Skills

+ Strong experience in root cause analysis and problem-solving within a manufacturing or quality environment.

+ Demonstrated ability to manage Non-Conformances (NC) and Corrective Action Preventive Action (CAPA) records.

+ Experience working with electronic quality management systems such as Track Wise for nonconformances, CAPAs, and complaints.

+ Ability to lead discussions and influence stakeholders at various levels, including Operations, Engineering, Regulatory, Compliance, and Suppliers.

+ Strong communication skills, especially when explaining resolution plans and quality decisions to technical and non-technical stakeholders.

+ Ability to work both independently and collaboratively within cross-functional teams.

+ Comfort working in stressful, time-sensitive situations while maintaining attention to detail and quality standards.

+ Experience or familiarity with manufacturing quality, continuous improvement, or supplier quality activities.

+ Ability to define requirements and collect objective evidence to support quality decisions and validations.

+ Capability to perform and interpret quality data analysis, monitor KPIs, and identify trends.

+ Comfort…