Description

Drive quality performance across the supply chain and manage supplier quality systems.

This role is on-site.

Responsibilities

• Develop and communicate quality expectations for sustaining parts and new products.
• Perform supplier surveys, quality system assessments, and process control audits.
• Conduct process and component validations, including F&T tests in Minitab.
• Lead investigations and root cause analyses for purchased materials.
• Collaborate with purchasing to monitor supplier metrics and drive corrective actions.

Required Skills

• 3-5 years of experience in Quality within the medical products industry.
• Experience in manufacturing or QA engineering in an FDA regulated environment.
• Proficiency in reading technical drawings and blueprints.
• Working knowledge of FDA cGMP, ANSI/ISO/ASQC, and CMDAS requirements.
• Hands-on experience with metrology, test equipment, and inspection techniques.
• Practical experience using fixtures and performing Gauge R&R.
• Competency in Minitab, Excel, Word, PowerPoint, and Access.
• Strong analytical problem-solving skills for CAPA.

Preferred Skills

• Experience with ISO 13485, QSR, and medical device quality system deployment.
• CQE, CSSBB, or CQA certifications.

Key Skills

Education

Bachelor's degree