Quality Assurance and Compliance Specialist
Thermo Fisher Scientific
Alajuela, Alajuela, CRI
hace 1 día

Job Title : Quality Specialist I

Job Code : OPS.QASP.P04

Department : Operations

Salary Band : 4

Job Track : Professional

Location : Coyol, Alajuela

Position Summary

The QA & Compliance Specialist drives day-to-day activities assuring the compliance of the products and services provided by the company in compliance with client and regulatory requirements.

The QA & Compliance Specialist will ensure the compliance of the Quality Management System, which includes quality assurances practices, internal and external audits, supplier management, complaints, nonconformance and corrections and corrective action activities, among others.

This position is part of the Operations and Logistics team.

The QA & Compliance Specialist will be part of the investigations of nonconformance product, complaints, change notifications, and process improvements.

In addition, they will evaluate and recommend process changes to improve performance and regulatory compliance.

The QA & Compliance Specialist will support the Operations and Logistics Manager in promoting quality disciplines, decisions and practices, and will apply systematic, problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues, including to promote a process improvement culture within the organization via PPI.

Main Responsibilities

  • Develop, maintain and monitor programs to be in compliance with the Quality Management System Regulations and internal procedures.
  • Maintain the vendor approved list, change notifications, quarantine notifications, correction and corrective actions, complaints, and supplier audit programs.
  • Supports the preparation for external and internal site audits.
  • Performs quality review of procedures, work instructions, records, etc. prior to implementation.
  • Enable collaborative relationships between Operations and Commercial departments with the overall focus of improving customer satisfaction.
  • Day-to-day tracking and monitoring of activities of the Quality Management System to assure compliance of all the stakeholders.
  • Work effectively as a member of cross-functional teams.
  • Provide guidance on QA aspects and ensure compliance through the processes.
  • Provides reporting, analysis and feedback on the QMS indicators, customer satisfaction surveys and supplier management, including a weekly or monthly report.
  • Drives quality delivery, productivity and cost savings of all site services
  • Participate actively within the company to promote the process improvement culture by implementing PPI activitites / methodology on the organization.
  • Reviews metrics and conduct trend analysis
  • Review compliance requirements of the company and meet the goals to assure requirements of the Free Trade Zone and Global Trade Compliance are met and accomplish in a timely manner.
  • Provides recommendations to Senior Management.
  • Perform duties in accordance with established company procedures and policies; perform other duties as assigned.
  • Qualifications

  • Degree in Industrial Engineering or related field.
  • 2 to 3 years’ experience related with Quality Assurance activities and managing a Quality Management System.
  • Excellent written and oral communication skills in English and Spanish
  • Proficiency with computer skills, specifically Microsoft office applications, with the ability to learn new computer systems quickly (Excel, Word, Power Point, Visio, Project)
  • Knowledge in ISO9001 : 2015 is required.
  • Knowledge in process improvement methodologies is preferred.
  • Competences

  • Excellent interpersonal skills
  • Creative problem-solving skills, organizational and time management skills.
  • Excellent oral and written communication skills.
  • Perform duties in accordance with established company procedures and policies; perform other duties as assigned.
  • Ability to work independently and as part of a team
  • Extremely adept in attention to detail / follow up
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