Quality Assurance Officer

Description

You'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. 

You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations that make the world healthier, cleaner and safer.

You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment.

Qualifications

Highest qualification: University

• Bachelor's Degree required. Experience in pharmaceutical, medical device or regulated industry preferred
• Preferred Fields of Study: Chemistry, Biology, Biotechnology, Engineering, or related scientific/technical field
• Additional certifications in Quality Systems or GMP desirable but not essential
• Knowledge of cGMP, ISO standards (13485/9001), and international regulatory requirements
• Experience with quality systems and documentation including batch records, SOPs, deviations, CAPA
• Proficiency in quality management software systems (TrackWise, SAP, etc.) advantageous
• Demonstrated ability to perform detailed documentation review and quality assessments
• Strong analytical and problem-solving skills for quality investigations and root cause analysis
• Excellent written and verbal communication skills
• Ability to work independently and collaborate effectively with cross-functional teams
• Experience conducting internal quality audits and supporting external regulatory audits
• Proficient computer skills including Microsoft Office applications
• Strong attention to detail and commitment to accuracy
• Ability to prioritize and adapt in a changing environment
• Experience with continuous improvement methodologies (Lean, Six Sigma) preferred
• Must be able to work in controlled environments wearing required PPE