Quality Engineer

Quality Engineer

The Quality Engineer supports medical device development and manufacturing projects by ensuring compliance with regulatory requirements, quality standards, and internal procedures. This role focuses on building and maintaining robust quality systems, supporting design control activities, and driving continuous improvement initiatives to enhance product safety and effectiveness across the entire product lifecycle.

• Develop, implement, and maintain quality systems in accordance with FDA QSMR requirements.
• Support design control activities, including risk management, verification and validation, and design transfer for medical device products.
• Conduct thorough root cause analysis and lead corrective and preventive actions (CAPA) to address quality issues.
• Collaborate closely with cross-functional teams such as R&D, Regulatory Affairs, Manufacturing, and Supply Chain to ensure quality is integrated throughout the product lifecycle.
• Review and approve validation protocols, reports, and test methods to confirm they meet regulatory and internal quality requirements.
• Ensure ongoing compliance with Good Manufacturing Practices (GMP) and applicable quality and regulatory standards.
• Support internal and external audits, inspections, and regulatory submissions by preparing documentation and participating in audit activities.
• Drive continuous improvement initiatives in quality processes and systems to enhance efficiency, compliance, and product performance.
• Manage nonconformance handling processes, including investigation, documentation, and implementation of corrective actions.
• Apply structured problem-solving tools, such as FMEA, 5-Why, and Fishbone diagrams, to identify and mitigate risks.

• Bachelor's degree in engineering, Life Sciences, or a related field.
• 3–5 years of experience in quality engineering within medical devices or other regulated industries.
• Strong knowledge of ISO standards, FDA QSMR requirements, and risk management standards applicable to medical devices.
• Hands-on experience with CAPA processes, nonconformance handling, and root cause analysis tools such as FMEA, 5-Why, and Fishbone diagrams.
• Familiarity with validation processes, including IQ, OQ, and PQ, and the use of statistical techniques in quality validation and analysis.
• Excellent communication skills, with the ability to clearly present quality issues and solutions to cross-functional teams.
• Strong documentation skills for preparing and maintaining quality records, protocols, reports, and regulatory documentation.
• Proven problem-solving abilities, with a structured and analytical approach to identifying issues and implementing effective solutions.
• Ability to work independently with minimal supervision while also collaborating effectively in cross-functional team environments.

• Experience with software validation activities in a regulated environment.
• Familiarity with electronic quality management systems (eQMS).
• Knowledge of Six Sigma or Lean methodologies and their application to quality and process improvement.
• Prior involvement in new product development projects, particularly within medical devices or other regulated industries.
• Audit-related certification, such as ISO Lead Auditor, is a plus and supports participation in internal and external audits.

The role operates within a regulated medical device development and manufacturing environment that emphasizes compliance, documentation, and continuous improvement. You will work closely with cross-functional teams including R&D, Regulatory Affairs, Manufacturing, and Supply Chain, using quality systems aligned with FDA QSMR, GMP, and ISO standards. The position involves frequent interaction with validation activities, audits, and electronic quality management tools, with a focus on structured problem-solving and data-driven decision-making.

Work hours typically follow standard business schedules, with occasional flexibility to support audits, inspections, or project milestones. Professional attire appropriate for office and regulated manufacturing or laboratory areas is expected, and you may spend…