Quality System Engineer

Rogers Foam Tijuana; Tijuana; Presencial; USD 30,000 - 45,000; Jornada completa

Descripción de la vacante

A leading company in Tijuana seeks a talented Quality Assurance professional. The ideal candidate will possess a strong background in regulatory compliance, internal audit processes, and a Bachelor’s degree in engineering. Responsibilities include conducting audits, ensuring compliance with international standards, and leading a team of internal auditors.

Formación

• 5+ years of experience in manufacturing environments.
• Experience participating in Quality Audits.

Responsabilidades

• Perform regulatory and system internal audits, ensuring compliance with ISO9001:2015 and ISO13485:2016.
• Develop and lead internal auditor teams, following up on Corrective/Preventive Actions (CAPA).

Conocimientos

Investigations

Root Cause Analysis

Statistics

Quality Systems

Statistical Techniques

Educación

Bachelor’s Degree in Industrial, Electrical, Systems or Mechanical Engineering

Descripción del empleo

RESPONSABILITIES

• Expertise regarding current regulatory requirements and international standards.
• Performs regulatory and system internal audits to ensure systems are documented, procedures are followed and are adequate according to ISO9001:2015, ISO13485:2016 and 21 CFR Part 820.
• Ensure that all the Quality System Procedures are in compliance with the international standards and regulatory requirements.
• Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
• Prepares internal audit plans and identifies the roles and responsibilities of audit team members.
• Ensure that internal audit plan is followed and completed according to the approved annual audit plan.
• Participate as Internal auditor leader to develop the rest of the internal auditor’s team
• Follow up corrective / preventive actions generated by internal and external audits to ensure that are documented and completed properly.
• Prepares audit reports by collecting, analyzing, and summarizing operating information and trends and report audit results.
• Responsible for the CAPA system, ensuring that all the corrective / preventive actions are documented and closed according to the implemented procedures.
• Responsible to complete the effectiveness verification for all the CAPAs generated
• Perform and/or lead failure investigations for CAPA and/or audit findings investigations.
• Support during internal and external audits

JOB REQUIREMENTS

• Bachelor’s Degree in Industrial, Electrical, Systems or Mechanical Engineering.
• 5+ years of experience in manufacturing environments
• Investigations, Root Cause Analysis and the application of statistics to the practice of Quality Assurance.
• Experience participating in Quality Audits
• Knowledge of statistical techniques, acceptance sampling, and SPC.

QUALIFICATIONS AND SKILLS

• Knowledge of Quality Systems, ISO13485:2016 Standard
• FDA Regulations