Senior Quality Engineer

Job Title: Senior Quality Engineer

Job Overview:

We are a leading provider of contract manufacturing services, specializing in advanced pharmaceutical and medical device solutions, including combination products like autoinjectors. As we expand our capabilities, we are seeking a skilled Senior Quality Engineer, to develop and maintain robust quality management systems that comply with FDA QSR (21 CFR Part 820), ISO 13485:2016, and EU MDR 2017/745. Reporting to the Head of Quality Systems, this role will provide technical leadership to support diverse client programs across U.S. and European markets, ensuring compliant, reliable, and scalable quality processes that enable the delivery of critical medical products to patients.

Job Responsibilities:

• Design and implement comprehensive quality management systems that meet FDA QSR (21 CFR Part 820), ISO 13485:2016, and EU MDR 2017/745 requirements.
• Develop and maintain adaptable quality procedures, master quality documentation, SOPs, and process frameworks to support contract manufacturing for FDA- and EMA-regulated products.
• Create client-specific quality and technical agreements to define quality responsibilities for U.S. and EU markets.
• Establish design controls and quality systems for medical device manufacturing in compliance with FDA QSR and EU MDR standards.
• Perform quality system assessments and collaborate with external auditors to demonstrate compliance with FDA, ISO 13485, and EU MDR regulations.
• Conduct risk assessments aligned with ISO 14971 and EU MDR risk management principles.
• Work closely with cross-functional teams, including technical services, validation, and manufacturing, to integrate quality and risk management practices during product introduction.
• Provide technical expertise for investigations, continuous improvement efforts, and routine production activities across multiple product lines.
• Support client regulatory submissions by supplying quality system documentation for FDA, EMA, and Notified Body requirements.
• Ensure change controls for medical device products are accurate and managed within the organization’s change control system.
• Act as a subject matter expert for quality systems, representing the quality function on project teams and communicating technical updates and expertise to clients.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline required; advanced degree in quality, regulatory, or sciences preferred.
• 6+ years of experience in quality systems for medical devices, with expertise in U.S. and European regulatory compliance.
• In-depth knowledge of FDA QSR (21 CFR Part 820), ISO 13485:2016, and EU MDR 2017/745.
• Familiarity with EMA guidance, MDCG guidelines, and Notified Body expectations.
• Experience with CE marking processes, technical documentation, and authorized representative interactions.
• Proficiency in ISO 14971 risk management principles and practices.
• Proven ability to troubleshoot complex quality issues, lead investigations, and implement corrective/preventive actions.
• Strong skills in cross-functional collaboration and client communication across diverse regulatory environments.

Additional Preferences:

• 3+ years of experience in contract manufacturing or CMO environments preferred.
• Direct experience establishing FDA QSR, ISO 13485, and EU MDR-compliant quality systems in a GMP setting.