Quality Systems Analyst I

Plexus; Región Centro; On-site; MXN 260,000 - 420,000; Full time

Job summary

Plexus Corp. is seeking a quality professional to assist with audits, CAPA, and continual improvement of the Quality Management System in a professional office setting in Mexico. The role supports regulatory alignment across sites and communicates requirements to internal customers.

Required is a Bachelor's degree with 1+ year of related experience, strong communication, and attention to detail. Travel is expected to be less than 40%.

Qualifications

• Bachelor's Degree with 1+ years of related experience preferred.
• Equivalent combination of education and/or experience considered.
• Self-motivated with ability to work independently and in a team.
• Good oral and written communication skills.
• Attention to detail, good problem solving skills, and computer literacy.

Responsibilities

• Participate in internal and external audits for various market sectors and maintain the audit schedule.
• Support or coordinate corrective and preventive actions with timely reporting.
• Work on special projects to improve the quality management system and related documentation.
• Establish regulatory guidelines and ensure compliance with standards (ISO 9001, ISO 13485, AS 9100, Nadcap, ISO 14001).
• Assist in communicating quality system and regulatory requirements to internal customers.

Skills

Self-motivated

Team player

Communication skills

Attention to detail

Problem solving

Computer literacy

Education

Bachelor's degree with 1+ year experience

Tools

Microsoft Office

Job description

Purpose Statement

Aid in ensuring compliance and continual improvement activities for the Plexus Quality Management Systems.

Key Job Accountabilities

• Participate and assist with internal and external audits for applicable market sectors including customer audits/visits, regulatory inspections and registrar/certification audits as requested. This may include assisting to maintain the internal audit schedule.
• Support or coordinate Corrective and Preventive actions to ensure timely response, follow through, and appropriate reporting to management.
• Work on special projects as requested to improve the quality management system, which may include assisting with process validations, or documentation such as assembly build instructions, device travelers, certificates of compliance, complaint files, DMRs, DHRs, etc.
• Assist to establish regulatory guidelines and industrial standards in quality system and work with site quality managers to ensure compliance at sites/region. Remain abreast of new and ever-changing applicable quality system standards and regulatory requirements. Relevant standards may include ISO 9001, ISO 13485, AS 9100, Nadcap, ISO 14001, etc.
• Supports the design and installation of the quality system. Assists to communicate quality system and regulatory requirements with internal customers.

Education/Experience Qualifications

• Bachelor's Degree with 1 or more years of related experience is preferred. An equivalent combination of education and/or experience will be considered.

Other Qualifications

• Employee must be self‑motivated with the ability to work independently and in a team environment.
• Good oral and written communication skills are necessary.
• Attention to detail, good problem solving skills, and computer literacy are essential.
• Project management a benefit, but not required.

Physical Requirements

• Professional office environment with suitable lighting, comfortable temperatures, and low noise level. May require prolonged periods of sitting at a desk, using a computer, and other office equipment. Minimal physical activity is generally involved, emphasizing the importance of good posture and ergonomic workplace arrangements.

Travel Requirements

• Less than 40%

This document does not represent a contract of employment and is not intended to capture every possible assignment the incumbent could be asked to perform.