Senior Quality Assurance Specialist

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Senior Quality Assurance Specialist

Position Overview

The Senior QA Specialist leads CAPA activities and supports the QMS and site Quality Operations.

The role investigates, escalates, resolves, and prevents quality issues while ensuring regulatory and procedural compliance.

The position leads complex investigations, monitors QMS performance and trends, supports quality governance, and drives improvement.

It works across functions to ensure products, processes, and quality systems meet requirements.

Reporting to the Manager, QA Operations, the Senior QA Specialist provides technical leadership and guidance across site Quality Systems and operations to support compliance, inspection readiness, issue prevention, and sustainable improvement.

Responsibilities



* Lead the CAPA program from initiation through closure, including action planning, effectiveness verification, performance monitoring, escalation, governance reporting, and guidance to cross-functional teams.



* Support the implementation, maintenance, and improvement of the QMS, including development and training of procedures, work instructions, forms, and related documentation.



* Ensure quality records and documentation are complete, accurate, compliant, and maintained in accordance with applicable procedures and record retention requirements.



* Analyze and report quality system data, trends, and investigation results to identify risks, support management review, and drive sustainable improvements.



* Serve as a Quality specialist supporting manufacturing, engineering, validation, supply chain, technical operations, and other product realization functions.



* Provide Quality oversight and support for nonconforming product investigations, deviations, change controls, risk assessments, validation activities, product disposition decisions, and continuous improvement initiatives.



* Support containment activities, impact assessments, and investigations associated with significant product quality, patient safety, or regulatory compliance concerns.



* Support internal audits, supplier audits, customer audits, regulatory inspections, and certification audits.

Required Knowledge/Skills, Education, and Experience



* BSc in engineering, life sciences, chemistry, QA, regulatory affairs, or a related discipline.



* Minimum five years of experience in the medical device, IVD, pharmaceutical, biotechnology, or a similar regulated industry.



* Experience leading CAPAs, root cause analyses, and QMS improvements.



* Ability to work independently/autonomously with over...