Quality Assurance Engineer

Qualifications & Experience

• 0–2 years of experience in Quality Assurance or Regulatory Affairs; manufacturing industry experience preferred.
• Familiarity with ISO 13485, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).
• Understanding of engineering and quality principles, including CAPA, risk management, audits, and statistical methods.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Strong analytical, problem-solving, written, and verbal communication skills.
• Excellent attention to detail and organizational skills.
• Ability to build effective relationships with internal teams, suppliers, and stakeholders.
• Comfortable representing Quality in cross-functional environments.
• Self-motivated and able to manage multiple priorities in a fast-paced manufacturing environment.
• Team-oriented with a customer-focused approach and a continuous improvement mindset.
• Excellent written and spoken English.
• Ability to work with a multi-site team; occasional travel may be required.

Preferred Qualifications

• Knowledge of risk-based thinking and statistical quality concepts.
• Familiarity with manufacturing process risk assessment and continuous improvement methodologies.

DR2