Jr. Quality Assurance Engineer

Jr. Quality Assurance Engineer

Department: Quality

Employment Type: Full Time

Location: EMEA-Poland-AFAB

The Quality Specialist supports the maintenance and continuous improvement of the site Quality Management System. The role focuses on process and quality improvement, complaint handling, root cause investigations, corrective and preventive actions, risk analysis, document control and change control activities.

The position works closely with supervisors, technicians, engineers, trainers, process owners and other cross‑functional stakeholders to ensure that quality requirements, objectives and deadlines are met. The Quality Specialist also supports internal, corporate and external inspections and helps ensure compliance with applicable regulations, internal policies and company procedures.

The position reports directly to the Quality Manager.

• Identify and analyze opportunities for continuous improvement of processes and product quality, with a focus on meeting and exceeding customer expectations.
• Support internal and cross-functional teams in process and quality improvement initiatives.
• Ensure that appropriate quality documentation is established, implemented, maintained and effective.
• Improve quality documentation in response to operational, regulatory and business needs.
• Coordinate complaint handling and root cause investigations for local departments.
• Work with supervisors, technicians, engineers, training teams and other relevant stakeholders to identify root causes and implement appropriate corrective actions.
• Coordinate local Corrective and Preventive Action activities and monitor the effectiveness of implemented actions.
• Conduct or participate in risk assessments related to processes, products and designs.
• Support corporate and external regulatory inspections related to the Quality Management System.
• Ensure that appropriate quality controls are implemented and maintained within operational processes.
• Support, guide and coach process owners and stakeholders on quality-related requirements and activities.
• Monitor the completion of assigned quality objectives, actions and deadlines.
• Ensure that site document control procedures comply with local and country-specific regulations, as well as internal policies and procedures.
• Ensure that document translations are properly reviewed and controlled.
• Maintain and support the site change control process within the Align Electronic Document Management System.
• Review change control documentation, supporting evidence and required deliverables.
• Assist in resolving documentation-related issues, including change control, document archiving, procedures and translations.
• Review electronic documents for formatting, spelling, consistency and clarity before approval.
• Co‑administer the Align electronic documentation management system.
• Participate in departmental and company‑wide initiatives and support the achievement of organizational goals.
• Perform other duties as assigned.

• Bachelor’s degree or an equivalent combination of education and professional experience.
• At least six months to one year of experience in a quality, compliance or Quality Management System-related role.
• Previous experience with document control, change control, CAPA, complaint handling or root cause analysis is an advantage.
• Native‑level proficiency in the local language.
• Very good written and spoken English, at a minimum B2 level.
• Understanding of Quality Management System principles and quality assurance processes.
• Knowledge of continuous improvement, root cause analysis and corrective and preventive action methodologies.
• Familiarity with risk assessment and risk management principles.
• Knowledge of document control and change control processes.
• Ability to interpret and follow internal procedures, quality standards and regulatory requirements.
• Very good proficiency in Microsoft Office.
• Experience with electronic document management systems is an advantage.
• Strong analytical, research and problem-solving skills.
• Ability to develop creative and compliant solutions to Quality Management System challenges.
• High level of accuracy and attention to detail.
• Good decision-making skills.
• Strong interpersonal and communication skills.
• Ability to work independently and collaborate effectively within cross-functional and interdisciplinary teams.
• Ability to guide, support and coach process owners and other stakeholders.
• Open-minded and resilient approach to working in a fast-paced environment.
• Strong organizational and follow-through skills, with the ability to complete projects within agreed deadlines.
• Ability to manage multiple tasks and priorities in a highly customized working environment.

Additionally, the position is eligible for a performance bonus.

• Private healthcare (Luxmed)
• Multisport card
• Private insurance
• Meal vouchers
• Co‑financing of company products
• Employee Support Program