Night-Shift Quality Operations Lead

Baxter Healthcare; Facatativá; On-site; COP 80,911,000 - 113,276,000; Full time

Job summary

Baxter Healthcare in the Dominican Republic is seeking a Quality Supervisor to ensure compliance with Quality System Regulations and provide technical support to the Haina facilities to guarantee robust process control.

You will participate in protocols, NCRs and CAPA, investigations, and audits; drive quality improvements; and collaborate with Manufacturing, IT, Process/Product and Automation Engineering. Bilingual English/Spanish and night shift availability are required.

Qualifications

• BS degree in science, engineering or related discipline.
• 3 years of experience in medical device industry, ideally in quality.
• Over 1 year of supervisory experience and knowledge of statistics.
• Fully bilingual (English & Spanish).
• Willingness to work night shift 11:00pm–7:00am.

Responsibilities

• Participate and maintain full knowledge of Operations / Management Review.
• Participates in the process validation and protocols of equipment and/or new subassemblies.
• Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies.
• Support the design, development enhancement of new product processes and technologies.
• Evaluation of customer complaints and implementation of corrective and preventive actions.
• Active participation and support on Nonconformances (NCR, CAPA, etc.) and part of multidisciplinary team (as applicable).
• Owner of action items and investigations associated to internal or external audits.
• Develop and evaluate Quality Sampling Plans techniques for further improvement.
• Meets with manufacturing, IT, Process/Product and Automation Engineering to assist in the implementation/evaluation of new or improve process and for equipment.
• Verify DHR documentation and assure that applicable specifications and local procedure are followed. Responsible for shipping disposition of final product or sub-assemblies.
• Responsible for reworks execution, retentions administration, quarantine cages and overtime work for directs reports.
• Evaluate failure modes associated with product and process changes.
• Owner of medium & high complexity Quality improvement Projects.

Skills

Supervisory experience

Statistical applications knowledge

Bilingual English & Spanish

Education

BS Degree in science/engineering

Job description

Baxter Healthcare in the Dominican Republic is seeking a Quality Supervisor to ensure compliance with Quality System Regulations and provide technical support to the Haina facilities to guarantee robust process control.

You will participate in protocols, NCRs and CAPA, investigations, and audits; drive quality improvements; and collaborate with Manufacturing, IT, Process/Product and Automation Engineering. Bilingual English/Spanish and night shift availability are required.