Quality Assurance Engineer

This position is ideal for mid-level quality professionals to join the QARA team as a Quality Assurance Engineer, supporting manufacturing operations and ensuring compliance with quality management requirements. Partnering with manufacturing, cross-functional, and site stakeholders, you’ll drive quality assurance activities, process improvements, complaint handling, CAPA management, audits, and regulatory compliance. This role plays a critical part in maintaining product quality, process effectiveness, and adherence to medical device quality standards while supporting continuous improvement initiatives across the organization.

Key Responsibilities

• Support manufacturing business functions in product quality and environmental compliance across dedicated operational areas.
• Act as a local quality partner for discussions related to PFMEA, non-conformances, CAPAs, product quality, and safety requirements.
• Define quality and validation requirements associated with process changes and collaborate with local teams on implementation.
• Interpret and apply applicable regulatory requirements, quality standards, and industry regulations.
• Identify, analyze, and lead continuous improvement initiatives focused on process and product quality enhancement.
• Support internal and cross-functional teams in quality improvement and operational excellence activities.
• Ensure quality documentation is established, maintained, effective, and continuously improved.
• Coordinate complaint handling, root cause investigations, and corrective and preventive action (CAPA) activities.
• Participate in risk assessments related to processes, products, and design activities.
• Support regulatory, corporate, and external audits and inspections related to the Quality Management System.
• Conduct internal and supplier audits to verify compliance with quality requirements and standards.
• Ensure appropriate quality controls are implemented and maintained throughout manufacturing processes.
• Serve as a subject matter expert for quality processes, providing guidance and coaching to process owners and stakeholders.
• Maintain site document control and change control processes, ensuring compliance with local regulations and internal procedures.
• Review quality documentation, change controls, document archives, translations, and EDMS records for compliance and accuracy.
• Support administration and maintenance of the electronic document management system (EDMS).

Skills, Knowledge & Expertise

Education: Bachelor’s degree in chemistry, Engineering, Quality, or a related discipline, postgraduate studies in Quality Management are preferred. Experience: Minimum 3+ years of experience in a quality or compliance role within medical devices or other regulated industries. Strong understanding of Quality System regulations including 21 CFR, ISO 13485, MDR 2017/745, and GMP. Skills: Practical knowledge of problem-solving methodologies, production processes, validation methods, statistical analysis, Minitab, SPC, ISO 13485, and Microsoft Office tools including MS Project. Communication: Strong written and verbal communication skills with the ability to synthesize and present information effectively. Fluent English communication skills are required. Teamwork: Ability to collaborate across interdisciplinary teams, build strong relationships, work independently, and perform effectively in a fast-changing environment.

Complementary skills

• Black Belt or Green Belt certification preferred.
• ISO 13485 Internal Auditor certification preferred.
• Goal-oriented mindset with strong interpersonal skills and the ability to manage multiple priorities under pressure.
• Experience with document control systems, change management processes, CAPA, audits, and continuous improvement initiatives.