Quality Engineer

Role Overview

Join our Quality Assurance department as a Quality Engineer focused on delivering quality support across operations and project activities. This position demands expertise in validation processes and hands-on quality operations within a regulated manufacturing environment, ensuring all practices align with regulatory standards and company protocols.

Primary Responsibilities

• Provide ongoing quality engineering assistance to manufacturing operations to uphold product standards.
• Conduct thorough investigations into quality incidents, deviations, non-compliances, and customer issues.
• Support root cause analyses, implementing corrective and preventive measures (CAPA) to address quality concerns.
• Review and authorize quality documentation such as procedures, work instructions, and batch records where relevant.
• Facilitate change control processes and evaluate impacts on quality.
• Track quality indicators to identify areas for ongoing enhancement.

• Develop, assess, and perform validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), process, and cleaning validations.
• Assist with equipment, utility, and process qualification activities ensuring regulatory adherence.

• Serve as the quality representative within cross-functional project teams to integrate quality requirements from project inception through completion.
• Support activities related to new product introductions, technology transfers, and upgrades of facilities or equipment.
• Review project documentation for compliance from a quality standpoint.
• Engage in risk assessments and design reviews that influence project outputs.

• Maintain adherence to GMP, ISO standards, and other regulatory mandates.
• Assist with both internal and external audits as well as regulatory inspections.
• Participate in continuous improvement initiatives utilizing methodologies like Lean and Six Sigma.
• Promote and cultivate a quality-driven culture within the organization.

Required Qualifications and Experience

• Bachelor's degree in Engineering, Science, Quality, or related fields.
• At least 3 to 5 years of experience in a regulated manufacturing industry such as pharmaceuticals, medical devices, or biotechnology.
• Proven background in quality operational support and validation activities.
• Experience working on projects related to new equipment, process enhancements, or capital investments is highly desirable.

Knowledge and Skills

• Deep knowledge of GMP and quality management systems.
• Familiarity with all phases of the validation lifecycle.
• Understanding of CAPA processes, deviation management, change control, and risk management strategies.
• Experience conducting internal and external audits.
• Awareness of regulatory guidelines including FDA, EU GMP, ISO 13485, and ISO 9001 standards applicable to the sector.
• Strong abilities in documentation and technical report writing.

Key Competencies

• Excellent analytical and problem-solving capabilities.
• Effective communication and stakeholder relationship management.
• Ability to collaborate across diverse functional teams.
• Meticulous attention to detail and dedication to quality standards.
• Strong organizational skills and capacity to manage multiple priorities efficiently.
• Adaptable mindset focused on continuous improvement.

Desirable Skills

• Competence in statistical analysis and quality tool application.
• Certification in Lean Six Sigma Green Belt or equivalent.
• Experience with electronic quality management systems (eQMS) and digital quality processes.
• Knowledge of data integrity principles within quality systems.