Quality Engineer - Medical Manufacturing

As a Quality Engineer, you’ll play a key role in validation, risk management, problem solving, and new product development. You will:

• →Evaluate specifications, requirements, and design documents and provide timely, valuable feedback to internal and external customers.
• →Develop detailed, well-structured validation plans using IQ/OQ/PQ methodology.
• →Estimate, prioritize, plan, and coordinate validation activities to ensure compliance with regulatory, internal, and customer requirements.
• →Ensure validation documentation is complete, accurate, and compliant with established requirements.
• →Lead or support FMEA and risk assessment activities with internal and external teams.
• →Support root-cause investigations for non-conformances and contribute to effective corrective actions.
• →Apply quality tools, data analysis, and structured problem-solving techniques to identify opportunities for continuous improvement.
• →Partner with engineering, manufacturing, and other cross-functional teams to support new product development and production, ensuring products consistently meet customer expectations.

We’re looking for someone who combines strong analytical thinking with a practical, collaborative approach to quality.

• College degree or 4+ years of Quality Engineering experience.
• Previous GMP and ISO 13485 experience highly desired
• Experience or knowledge of quality engineering principles and quality tools.
• Experience with or understanding of validation activities and IQ/OQ/PQ methodology.
• Knowledge of FMEA and risk assessment methods.
• Ability to perform data analysis and problem solving using quality tools.
• Strong analytical, organizational, and communication skills.
• Ability to work effectively with internal and external customers and cross-functional teams.
• Understanding of manufacturing safety practices.
• Strong attention to detail and commitment to quality documentation.

Quality Engineering is more than documentation and compliance—it’s about preventing problems, improving processes, and delivering products customers can trust. In this role, you’ll have the opportunity to influence products and processes from development through production while working with teams across the organization.