Senior Quality Engineer Job

Summary

The Senior Quality Engineer is responsible for maintaining and improving the Quality Management System (QMS) across the product lifecycle—from design and development to manufacturing and post-production. This role leads CAPA and risk assessment activities, supports supplier quality programs, manages engineering projects, and ensures compliance with regulatory standards through audits and validations.

Key Responsibilities

* Lead CAPA investigations and risk assessments for new and existing products.
* Support daily manufacturing activities and resolve line issues.
* Develop and maintain quality systems, procedures, and documentation.
* Provide technical support for incoming inspection and lot release testing.
* Manage customer complaints and non-conformance investigations.
* Lead internal and external audits (FDA, ISO, MDD).
* Oversee supplier quality activities including audits and corrective actions.
* Support engineering teams in product development and process improvements.
* Conduct statistical analysis, validation testing, and Gage R&R studies.
* Mentor junior quality staff and provide training as needed.

Qualifications

* Bachelor’s degree in engineering, science, or related technical field.
* Minimum 8 years of quality engineering experience in regulated industries (medical device or pharmaceutical preferred).
* Strong knowledge of analog/digital circuits, embedded software, and hardware systems.
* Experience with ISO 13485, ISO 14971, FDA QSR, IEC 60601, and related standards.
* Proficiency in statistical tools and software (Minitab preferred).
* ASQ certifications (CQE, CQA) and Six Sigma Green/Black Belt preferred.
* Excellent communication, technical writing, and project management skills.
* Ability to travel up to 10%.

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