Position Overview:
We are seeking a Quality Specialist with at least 3 years of experience to join our Quality team in ensuring compliance with medical device regulations and quality standards. The role involves supporting quality assurance and control activities across manufacturing processes for medical device products.
*** No sponsorship available, only available to those with full right to work ***
Key Responsibilities:
* Implement and maintain Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations.
* Conduct inspections, testing, and release activities for components and finished medical device products.
* Support internal and external audits, including preparation, participation, and follow-up on corrective actions.
* Collaborate with cross-functional teams to address non-conformities, deviations, CAPAs, and complaints to drive resolution and compliance.
* Assist in the validation of manufacturing processes, equipment, and software (IQ/OQ/PQ).
* Review and approve batch records, change control documents, and quality-related documentation.
* Maintain and update quality records, including product inspection reports, NCR logs, and calibration schedules.
* Support risk management processes (ISO 14971) and ensure adherence to design control requirements.
* Train staff on quality standards, procedures, and best practices.
* Monitor trends, metrics, and KPIs to identify and implement continuous improvement opportunities.
Required Qualifications:
* Bachelor’s degree in Engineering, Life Sciences, or a related field.
* Minimum of 3 years of experience in quality assurance or quality control within a medical device environment (CMO experience preferred).
* Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and MDR requirements.
* Experience with CAPA, non-conformance investigations, and root cause analysis.
* Familiarity with validation protocols (IQ/OQ/PQ) and risk management principles (ISO 14971).
* Proficiency in MS Office Suite; experience with QMS software is a plus.
* Strong analytical, problem-solving, and communication skills.
Preferred Qualifications:
* Experience with Class I, II, or III medical devices manufacturing.
* Knowledge of sterilization processes, packaging validation, or cleanroom environments.
* Internal auditor certification (ISO 13485) or other quality certifications (e.g., CQPA, CQE) are a plus.
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