Supplier Quality Engineer

We are seeking an experienced Supplier Quality Engineer to support supplier part qualification and validation activities within a regulated medical device manufacturing environment. The ideal candidate will have strong hands-on experience with IQ/OQ/PQ, Measurement System Analysis (MSA), and supplier quality processes. This role involves working closely with external suppliers and cross-functional teams to ensure components meet quality, performance, and regulatory requirements.

• Lead supplier part qualification activities, including the development and execution of IQ, OQ, and PQ protocols.

• Perform Measurement System Analysis (MSA) to ensure measurement accuracy and process reliability.

• Collaborate with external suppliers to resolve quality issues and ensure component compliance.

• Review qualification data, identify gaps, and recommend corrective actions.

• Prepare and maintain validation protocols, qualification reports, and quality documentation.

• Work closely with Engineering, Manufacturing, and Quality teams to support supplier qualification and production readiness.

• Ensure qualification activities comply with applicable medical device quality standards and internal procedures.

• Bachelor's degree in Engineering is required.

• 5 7 years of professional experience in Supplier Quality Engineering or a closely related field.

• Medical device manufacturing industry experience is mandatory.

• Minimum 3 years of hands-on experience with IQ, OQ, PQ, and MSA.

• Strong understanding of supplier qualification, validation, and quality management systems.

• Proven experience working directly with external suppliers on component qualification.

• Ability to independently manage qualification activities with minimal supervision.

• Excellent analytical, technical documentation, communication, and problem-solving skills.