13 sep
|
Bepc
|
Ciudad Juárez
13 sep
Bepc
Ciudad Juárez
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.
Validation / NPI Engineer to support medical device manufacturing operations in a regulated environment. This role will focus on process validation, new product introductions, and quality assurance support, ensuring compliance with internal procedures and regulatory requirements.
KEY RESPONSABILITIES:
- Develop, execute, and document EIQ, IQ, OQ, PQ, and CSV validation activities.
- Support validation of new equipment, machines, and production lines.
- Participate in New Product Introduction (NPI) projects from development through production release.
- Prepare, review, and approve validation protocols, reports, and technical documentation.
- Support QA activities, including nonconformance management, defect classification, and rework approvals.
- Generate and manage Nonconformance Records (NCRs) using EtQ Reliance.
- Develop and update test methods and sampling plans.
- Perform capacity studies, data analysis, and process optimization.
- Maintain and update manufacturing documentation (BOMs, PFMEAs, specifications, drawings).
- Support preventive maintenance and equipment qualification activities.
- Collaborate with cross-functional teams (Manufacturing, QA, R&D;, Supply Chain)
QUALIFICATIONS:
- Bachelor’s degree in Engineering (Industrial, Systems, Computer, or related fields).
- 2 to 3 years of experience working with MES systems.
- Strong understanding of programming logic.
- Proficiency in SQL configuration language.
- Experience in data analysis and interpretation.
- Excellent problem-solving skills and attention to detail.
- Ability to work in a regulated environment with a focus on quality and compliance.
- Upper-intermediate level
📌 QA Engineer (Ciudad Juárez)
🏢 Bepc
📍 Ciudad Juárez