**Plastic Process Expert (Medical Device Manufacturing)** We are seeking a **Principal Plastic Process Expert** with a strong track record in precision medical device manufacturing. The ideal candidate will be a technical authority in polymer technology and optimization of **injection molding and extrusion**, core processes for our broad range of healthcare products. The candidate will be responsible for technical and operational excellence in the production of critical plastic components—from high-volume disposable items to complex assemblies. We seek an individual who drives quality and efficiency within a highly regulated environment governed by national and international standards such as **ISO 13485, ISO 9001, and NOM-241-SSA1**. Key Responsibilities * **Manufacturing Excellence:** Lead optimization of injection molding and extrusion process parameters to maximize performance and efficiency (**OEE**) in the production of high-tolerance plastic components. * **Quality Management:** Design and implement manufacturing processes compliant with **ISO 9001**, ensuring the plastic production quality system aligns with **NOM-241-SSA1** and **ISO 13485**. * **Validation and Qualification:** Lead and document Design and Process Qualification (**DQ, IQ, OQ, PQ**) for new equipment, molds, and production tooling in our Clean Rooms. * **Problem Solving:** Serve as the technical expert for root cause analysis of product defects related to process or material, implementing permanent corrective actions. * **Regulatory Compliance:** Ensure full adherence to **Good Manufacturing Practices (GMP)** and applicable regulations across all stages of plastic production. Essential Requirements * **Location and Schedule:** **Availability to work in Chalco, State of Mexico**, with working hours from **Monday to Friday and half-day on Saturday.** * Bachelor’s degree in Engineering (Processes, Materials, Mechanical, or related field). * Minimum of **7 years of progressive experience** in plastic manufacturing process engineering, with focus on **injection molding**, within the medical device industry. * Demonstrable experience implementing and maintaining quality management systems under **ISO 9001** and **ISO 13485**. * **Mandatory, hands-on knowledge of NOM-241-SSA1 (Good Manufacturing Practices for Medical Devices).** * Proven history of high-volume process optimization and scrap reduction. What We Offer * Competitive salary based on experience * Professional growth opportunities Employment Type: Full-time Salary: Starting at $20,000.00 MXN per month Benefits: * Grocery vouchers Work Location: On-site