Quality Engineer

Job Description

About the Role:

The Quality Engineer plays a critical role in ensuring that products and processes meet stringent quality standards and regulatory requirements, particularly within the medical device industry. This position is responsible for developing, implementing, and maintaining quality systems that comply with ISO 13485 standards, thereby supporting product safety and efficacy. The Quality Engineer will lead efforts in statistical process control and root-cause analysis to identify and resolve quality issues proactively. They will collaborate closely with suppliers and cross-functional teams to drive continuous improvement initiatives and ensure first article inspections and control plans are rigorously executed. Ultimately, this role ensures that corrective and preventive actions are effectively managed to uphold the highest levels of product quality and customer satisfaction.

Minimum Qualifications:

Bachelor’s degree in Engineering, Quality Management, or a related technical field.

Proven experience with ISO 9001 quality management systems.

Experience with corrective and preventive actions (CAPA) and root-cause analysis techniques.

Familiarity with supplier quality management and first article inspection processes.

Preferred Qualifications:

Certification as a Quality Engineer (CQE) or equivalent.

Experience working in the Industrial equipment manufacturing industry.

Hands-on experience with quality management software and data analysis tools.

Advanced training in control plan development and implementation.

Responsibilities:

Develop, implement, and maintain quality management systems in compliance with ISO 9001 standards.

Perform statistical process control (SPC) to monitor and improve manufacturing processes.

Lead root-cause analysis investigations and implement corrective and preventive actions (CAPA) to address quality issues.

Coordinate and conduct first article inspections and supplier quality audits to ensure adherence to specifications.

Collaborate with suppliers and internal teams to resolve quality concerns and drive continuous improvement.

Prepare and present quality reports and documentation to support regulatory submissions and internal reviews.

Skills:

The required skills such as statistical process control and root-cause analysis are applied daily to monitor production quality and identify areas for improvement, ensuring that processes remain within defined control limits. Corrective and preventive actions are managed systematically to resolve non-conformances and prevent recurrence, maintaining product integrity. Supplier quality expertise is essential for evaluating and auditing suppliers to guarantee that incoming materials meet quality standards. First article inspection and geometric dimensioning skills are utilized to verify that new or modified products conform to design specifications before full-scale production. Additionally, knowledge of ISO 13485 and quality systems underpins all activities, ensuring compliance with regulatory requirements and fostering a culture of continuous quality improvement.

Full-time