Description

You will drive overall quality performance throughout the supply chain and manage supplier quality systems.

Responsibilities

• Develop and communicate expectations for quality performance, continuous improvement, and process controls 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 event investigations and root cause analyses for purchased materials and components.
• Collaborate with purchasing to monitor supplier performance metrics and drive corrective action plans.

Required Skills

• 3-5 years of experience in Quality or a related field within the medical products industry.
• Experience in manufacturing or quality assurance engineering within an FDA regulated environment.
• Proficiency in reading and interpreting technical drawings and blueprints.
• Working knowledge of FDA cGMP, ANSI/ISO/ASQC, and CMDAS requirements.
• Hands-on experience with metrology, test equipment, inspection, and analysis techniques.
• Practical experience using fixtures to measure parts and performing Gauge R&R.
• Competency in Minitab, Excel, Word, PowerPoint, and Access.
• Strong analytical problem-solving skills specifically related to CAPA.
• Ability to manage projects methodically and facilitate cross-functional teams.

Preferred Skills

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

Key Skills

Education

Bachelor's degree