Job Description: Quality Control Specialist (Manufacturing & Medical Devices)
Position Title: Quality Control Specialist
Location: Alajuela, Grecia. Costa Rica
Reports to: Quality Control Manager
Job Overview:
We are seeking a detail-oriented and highly skilled Quality Control Specialist to join our team in the manufacturing and medical devices industry. This role will be responsible for ensuring that all products meet rigorous quality standards and regulatory requirements. The ideal candidate will have a strong background in quality control processes, especially in manufacturing environments, and experience in working with medical devices.
Key Responsibilities:
Quality Control Testing and Inspection:
Conduct routine and final inspections of raw materials, in-process materials, and finished products to ensure compliance with company and regulatory standards. Perform testing on medical devices and components according to established protocols. Utilize precision measurement tools and equipment to verify product specifications.Documentation and Reporting:
Maintain accurate records of inspections, testing results, and quality control procedures. Prepare and submit detailed reports on quality findings, non-conformities, and corrective actions. Ensure compliance with internal and external documentation standards, including FDA regulations and ISO 13485.Non-Conformance Management:
Identify and document non-conformities and deviations from quality standards. Work closely with production and engineering teams to investigate root causes and implement corrective and preventive actions (CAPA).Compliance and Standards:
Ensure adherence to Good Manufacturing Practices (GMP) and relevant regulatory standards (e.g., FDA, ISO 13485). Assist in internal audits and inspections to assess compliance with quality standards.Continuous Improvement:
Contribute to the development and implementation of quality improvement initiatives. Suggest process enhancements to improve efficiency, quality, and safety.Collaboration:
Collaborate with the production team to ensure smooth transitions from raw materials to finished products. Work closely with R&D and engineering teams to evaluate new product designs and manufacturing processes for quality implications.Qualifications:
Bachelor’s degree in Engineering, Life Sciences, Quality Assurance, or related field (or equivalent work experience). At least 2-3 years of experience in quality control or quality assurance, preferably in a manufacturing or medical device environment. Strong knowledge of quality control methodologies, including inspection techniques, statistical analysis, and testing protocols. Familiarity with FDA regulations, ISO 13485, and other relevant quality standards in the medical device industry. Experience with precision measuring tools and testing equipment. Strong attention to detail and problem-solving skills. Ability to work in a fast-paced environment and meet tight deadlines. Excellent communication skills, both written and verbal.Preferred Qualifications:
Certification in Quality Control (e.g., CQE, CQA). Experience with software tools used for quality documentation (e.g., SAP, Minitab).