Quality Engineer

Job Description

We are seeking a Quality Engineer / Senior Quality Engineer to support manufacturing quality, supplier quality, and quality system activities within a regulated medical device environment. This individual will play a key role in ensuring products meet established quality standards throughout the manufacturing process while partnering closely with Manufacturing Engineering, Operations, and Suppliers.

The Quality Engineer will be responsible for developing inspection methods, leading nonconformance investigations, supporting CAPA activities, managing supplier quality initiatives, and participating in validation activities. This role requires a hands-on engineer who can work cross-functionally to identify root causes, implement corrective actions, and drive continuous improvement efforts within the Quality Management System (QMS).

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

• Bachelor's degree or higher in Engineering, Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related scientific discipline.

• Minimum 2+ years of experience in a Quality Engineering role within the medical device industry.

• Experience supporting manufacturing quality and production environments.

• Experience investigating nonconformances, performing root cause analysis, and implementing corrective actions (CAPA).

• Experience with validation activities, including process validation and/or equipment qualification.

• Experience developing inspection methods, procedures, and quality documentation.

• Experience working within a regulated environment and Quality Management System (QMS).

• Ability to analyze quality data and develop quality performance metrics.

Strong collaboration skills with Manufacturing, Operations, and cross-functional teams. • Medical device industry experience supporting Class II or Class III products.

• Experience with supplier quality, supplier audits, SCARs, and supplier performance management.

• Knowledge of ISO 13485 and FDA quality system requirements.

• Knowledge of ISO 14971 risk management methodologies.

• Experience with FMEA, risk assessments, and process risk management activities.

• Experience with statistical analysis tools and quality improvement methodologies.

• Previous experience in aerospace, highly regulated manufacturing, or pharmaceutical industries.

• Mechanical Engineering background with hands-on manufacturing or product engineering experience.

• Experience supporting environmental monitoring programs and cleanroom environments.

• Lead Auditor or Internal Auditor experience.

• Experience with CAPA systems, NCR investigations, and continuous improvement projects.

• Familiarity with electronic document control systems, cloud-based file management platforms, and quality management software.