Description

Manage supplier quality performance, process controls, and continuous improvement for sustaining parts and new product developments.

This role is on-site.

Responsibilities

• Develop and communicate expectations for quality performance, quality systems, and process controls.
• Perform and coordinate supplier surveys, quality system assessments, and process control assessments.
• Collaborate with purchasing to measure supplier performance against key metrics and drive continuous improvement plans.
• Lead event investigations and root cause analyses regarding purchased materials and components.
• Conduct process and component validations and monitor corrective action activities for assigned suppliers.

Required Skills

• Bachelor's degree.
• 3-5 years of experience in Quality or a related field within the medical products industry.
• Experience in manufacturing or quality assurance engineering in an FDA regulated environment.
• Lead Auditor or ISO Lead Assessor training with 1-2 years of experience in auditing techniques and interpreting regulations.
• Practical experience in metrology, test equipment, inspection, and analysis techniques.
• Working knowledge of FDA cGMP, ANSI/ISO/ASQC, and CMDAS requirements.
• Ability to read and understand blueprints and technical drawings.
• Proficiency in Word, Excel, PowerPoint, Minitab, and Access.
• Experience with standard operating procedures and 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