Quality Engineer IV

jabil; Ecatepec de Morelos; Presencial; MXN 180.000 - 240.000; Jornada completa

Descripción de la vacante

Jabil seeks a Quality Engineer to lead the Workcell QA operations and support the NPI team, ensuring product quality and regulatory compliance. You will drive quality plans, perform statistical analysis, and collaborate with manufacturing, engineering, and suppliers to resolve discrepancies.

The role requires a Bachelor’s degree with 7+ years in quality engineering and fluent English. Experience in medical device manufacturing and CAPA leadership is preferred; a CQE is a plus.

Formación

• Bachelor’s degree required; seven years related experience or equivalent.
• Proficiency in English, written and verbal.
• Experience in Medical Device industry and ISO 13485 knowledge.
• Certified Quality Engineer preferred (ASQ CQE).
• Strong problem solving and data analysis skills.

Responsabilidades

• Lead quality evaluation plans and protocols for materials and products.
• Develop and implement methods for inspecting and testing production.
• Support quoting in early design and development phases.
• Lead quality operations activities for product release testing.
• Approve batch records and revise manufacturing processes.
• Act as Validation Owner for validation activities.
• Ensure ISO 13485 CFR 21 Part 820 compliance and CAPA closure.
• Supervise QA Engineers, Inspectors, and Technicians.
• Participate in FDA quality audits as needed.

Conocimientos

Problem solving

Negotiation skills

English proficiency

Minitab

Quality statistics tools

Educación

Bachelor’s degree

Herramientas

Minitab

Quality statistics tools

Descripción del empleo

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world’s top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

SUMMARY Leads the Workcell Quality Operations or NPI team, Quality Engineers, technicians and inspectors. Implementsquality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and data analysis.Ensures that performance and product quality conform to the established company, customer and regulatory requirements.Reviews, analyzes and reports on quality discrepancies related to the assembly process. Leads investigation of problemsand develops dispositions, modifications, and corrective actions for recurring or non-recurring discrepancies. Interfaces withmanufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Leads the development, modification, and maintenance of quality evaluation and control plans and protocols forprocessing materials into partially finished or finished products.

• Owns the development and implementation of methods and procedures for inspecting, testing and evaluating theprecision and accuracy of products and production equipment.

• Provide support for all quoting activities by participating in the initial process design, development, andimplementation phases.

• Lead the plan quality operation activities, assuring the correct execution of quality tests for product release.

• Approve batch record documentation and revising of manufacturing processes.

• Serve as a Validation Owner. Responsible for the development, approval and execution of validation activities.

• Support plant Quality System software validation as needed.

• Assists validation owners ensuring that the validation processes are completed in accordance with the applicable ISOrequirements (ISO 13485), CFR 21 Part 820 and local procedure requirements.

• Leads the design and analysis of inspection and testing processes, mechanisms and equipment; conducts qualityassurance tests; and performs statistical analysis to assess the cost and determine responsibility for, products ormaterials that do not meet required standards and specifications.

• Assists with managing Part Files that define statistical analysis requirements and any associated control limits, as needed, for SPC.

• Audits quality systems for deficiency identification and correction.

• Assists in the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISOrequirements (ISO 9001 and ISO 13485), Jabil Problem Solving methods, and that documentation is complete andcompliant with requirements. May own CAPAs and serves as a leader for actions implementation.

• May specialize in the areas of production control, product evaluation, reliability, and/or research and development asthey apply to product or process quality.

• Stablish clear measurable goals and objectives by which to determine individual and team results (i.e.operational metrics, results against project timelines, training documentation, attendance records, knowledgeof operational roles and responsibilities, personal development goals).

• May supervise, train or provide mentoring to less experienced QA Engineers.

• Perform team member evaluations professionally and on time.

• May manage the internal supplier third party and participate in FDA quality audits.

• Recruit, interview and supervise Quality Engineers, Inspectors and Technicians.

• Foster good morale, a proactive and positive culture, and maximize the opportunity for personal growth within theworkcell QA Team Support all company safety and quality programs and initiatives.

• Responsible for the generation / updating / maintenance the Matrix for the direct reports.

• Comply and follow all procedures within the company security policy.

• Provide support to all Safety, Health and Environment (EHS) programs and initiatives in order to support our zero accidents culture.

• May perform other duties and responsibilities as assigned.

KNOWLEDGE REQUIREMENTS

• Problem solving skills: Develop technical solutions to complex problems, which require the regular use ofcreativity.

• Demonstrated effective negotiation skills and has the ability to work through obstacles.

• Demonstrated high level of competence in the ASQ Quality Engineering body of knowledge.

• Expert level in the use of Minitab and Quality Statistical tools.

• Able to provide technical recommendations in topics with a high level of complexity.

MINIMUM REQUIREMENTS

• Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skillsrequired.

• Certified Quality Engineer preferred (ASQ CQE).

• Bachelor’s degree required and seven years related experience; or equivalent combination of education and experience.

• Must be proficient in English, both written and verbal.

• Must have experience in the Medical Device industry and a strong understanding of ISO 13485 requirements and compliance.

• Knowledge of PCBA (Printed Circuit Board Assembly) manufacturing processes and electronic components is preferred.

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.

Accessibility Accommodation

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to [e-mail] with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.