Description

You will manage supplier quality engineering, manufacturing quality, and quality assurance processes to ensure compliance with regulatory and internal standards.

This role is hybrid.

Responsibilities

• Conduct supplier QMS and process audits against ISO 9001 standards.
• Perform root cause analysis and drive corrective action methodologies for quality issues.
• Execute risk assessments and quality audits using eQMS systems or digital audit tools.
• Ensure compliance with FDA, GMP, and other relevant regulatory standards.

Required Skills

• Bachelor’s degree in engineering, Quality, or a related technical field.
• 7+ years of experience in supplier quality engineering, manufacturing engineering, or quality assurance.
• Proficiency in Supplier Quality and Auditing methodologies.
• Strong problem-solving skills with expertise in root cause analysis.
• Experience with eQMS systems or digital audit tools.
• Familiarity with regulatory standards including FDA and GMP.
• Excellent communication and negotiation skills for supplier interactions.

Preferred Skills

• Willingness to travel for supplier audits and evaluations.

Key Skills

Education

Bachelor's degree