Sr. Quality Engineer - Supplier Focus

We are seeking a highly skilled and experienced Supplier Quality Engineer to champion the integrity of our supply chain. In this pivotal role, you will collaborate with suppliers and internal teams to ensure our products consistently meet stringent design and process specifications. Your expertise in quality engineering, coupled with your proficiency in tools like Pareto charts, Six Sigma/DMAIC, and root cause analysis, will be essential in driving continuous improvement and mitigating risks.

• Spearhead the evaluation of supplier change notifications, collaborating directly with suppliers and cross-functional teams to assess and approve or reject proposed changes, ensuring meticulous record-keeping.
• Drive improvements in product quality by working closely with suppliers to resolve quality issues, partnering with the Manufacturing Quality Engineering team to enhance supplier performance and maintain a reliable supply chain.
• Conduct audits of both prospective and current suppliers, contributing to supplier onboarding and maintenance activities, including contract negotiations and Approved Supplier List management.
• Analyze nonconformance data, supplier corrective actions, and deviations to identify trends, maintain scorecards, and generate supplier performance reports, enabling proactive risk mitigation through annual supplier risk plans.
• Contribute to the enhancement of global and site Supplier Controls procedures, such as supplier qualification, change notification, audit processes, and risk assessments, while initiating and approving engineering change requests as needed.
• Support the resolution of supplier-related nonconformances and corrective/preventive actions (sCAPA) by assisting in root cause analysis and ensuring proper documentation of objective evidence.
• Provide mentorship and guidance to junior team members, fostering a culture of continuous learning and development within the supplier quality engineering team.

Required Skills

• Bachelor’s degree or higher in a technical field (Engineering or Sciences).
• Minimum of 7 years of direct quality system experience or 10 years of quality-related experience within a regulated manufacturing industry.
• Proficiency in problem-solving methodologies and creative thinking.

Preferred Skills

• Demonstrated interpersonal skills, effective communication abilities, and a self-motivated approach.
• Ability to make sound decisions independently and work with minimal supervision.
• Familiarity with quality policies, procedures, and GMP (Good Manufacturing Practice) requirements.