Supplier Quality Engineer

About the role

ICU Medical is seeking a Supplier Quality Engineer to support supplier quality processes. The listed functions and responsibilities are illustrative, not limiting; the role may include other tasks related to the area’s objectives and strategies.

Responsibilities

• Conduct supplier audits when necessary and own the supplier quality metrics process.
• Train providers in root cause analysis tools.
• Evaluate article quality related to validations arising from repairs, new products, materials, or changes in supplier processes or molds (AQA).
• Follow up on supplier change requests (SCR) and investigate provider-related complaints.
• Verify effective supplier corrective actions and reduction of recurring problems.
• Know and apply policies and procedures for ISO 13485 Quality Systems, the Environmental Management System (ISO 14001), the Occupational Health and Hygiene and Safety Management System (Ohsas 18001), and other systems required for company operations.
• Adhere to the ICU Medical code of conduct, ethics, and dress.

Requirements

• Completed university degree in a related engineering field.
• 3–5 years of experience in a similar role in the medical device manufacturing industry.
• ASQ Quality Engineering and Certified Auditor credentials are preferred; SSGB certifications are preferred.
• Communication, human relations, coaching, and technical writing skills.
• Ability to analyze and solve problems.
• Strong knowledge of reading plans, dimensions, and geometric tolerances.
• Strong knowledge of statistical process control, measurement, and analysis systems.
• Knowledge of the FDA Quality System Standard ISO 13485.
• Ability to plan and conduct effective meetings and group presentations in Spanish and English.
• Ability to coordinate and lead cross-functional projects and team activities effectively and efficiently.
• Ability to work closely with suppliers to ensure quality improvement.

Datos clave

• Requires a completed university degree in a related engineering field.
• Requires 3–5 years of similar-role experience in medical device manufacturing.
• ASQ Quality Engineering, Certified Auditor, and SSGB certifications are preferred.