BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.
We are seeking a proactive and detail-oriented Senior Component-Supplier Validation Engineer to support component change validations and supplier interactions within the medical device industry. The ideal candidate will have a strong background in supplier quality and component-level validations, excellent communication skills, and the ability to manage multiple priorities effectively.
KEY RESPONSABILITIES :
- Lead and execute validation activities for component changes introduced by suppliers.
- Collaborate with Supplier Quality and Engineering teams to assess and approve component modifications.
- Ensure compliance with regulatory and quality standards during validation processes.
- Interface directly with suppliers to coordinate validation plans, documentation, and timelines.
- Analyze data and generate technical reports to support validation outcomes.
- Maintain clear and professional communication across cross-functional teams and external partners.
BASIC QUALIFICATIONS :
Bachelor’s degree in Engineering, Life Sciences, or a related field.Minimum 4 years of experience in the medical device industry, specifically in component-level validations.Prior experience in Supplier Quality or working closely with suppliers on component changes.Experience managing PLM (Product Lifecycle Management) systems such as Windchill, Siemens Teamcenter, etc.Experience managing ERP (Enterprise Resource Planning) systems such as JDE, SAP, or Oracle.Knowledge of validation protocols IQ, OQ and PQ (Must)Intermediate knowledge of statistics.Strong analytical, time management, and problem-solving skills.Excellent interpersonal and communication abilities.Advanced English proficiency (spoken and written).