Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
We are hiring Sr. Quality Engineer (Technical)!
For our Manufacturing facility at Apodaca
We’re looking for an experienced Sr. Quality Engineer (Technical) to join our team. Reporting directly to the Sr. Manager QA, you will be in charge of ensuring and providing support of Quality Engineering to the manufacturing operations. As well as, guarantying that the processes and machines of the site remain validated to function correctly.
Responsibilities:
•Support manufacturing and engineering areas regarding visual and functional quality criteria.
•Support in resolving quality problems both internal, and customer related.
•As quality partner, leads multifunctional groups to close corrective actions.
•Ensure that the processes and machines of the site remain validated in order to function correctly.
•Review and approve validation protocols and their reports, as well as provide support in their development.
•Makes sure that the master validation plan is completed on a timely manner.
•Ensures compliance and improvement of the Quality Management System by updating and maintaining the quality procedures of its function.
•Diagnose quality problems and provide technical assistance to resolve them.
•Planning and designing quality plans, control tests, methods, measurements and techniques
•Recommending equipment necessary to provide acceptable quality level
•Analyzing customer complaints and follow-up.
•Review and supervise all customer special requirements (preservation, packaging, cleaning, data reports, etc.)
•Research and involve respective departments to achieve immediate corrective/preventative action response to pertinent customer and internal CAPA's, as required.
•Maintain effective work instructions and operating procedures for inspection, operations and supplier quality assurance per ISO requirements.
•Release validations, transfers and new products
•Approval/Rejection of: process, product deviations, Scrap, material return, etc.
Profile:
•Engineering degree with 5 years of experience as Quality Engineer or equivalent (preferred in plastic injection manufacturing environment)
•Knowledge of ISO 9001, ISO 13485 and 21 CFR part 820.
•Application of Statistical methods (SPC, DOE, etc.)
•Bilingual
•Prospective applicants should be accurate, disciplined, self-motivated, have strong leadership skills, ability to manage multiple priorities and negotiate, develop and maintain constant relationship with suppliers, proactive team and result oriented.
