Quality Process Engineer -REGULATED ENVIRONMENT

Quality Process Engineer

Location: Manchester, NH (100% onsite)

How you will make an impact:

As a member of the Quality team, the Quality Process Engineer focuses on ensuring the quality and efficiency of manufacturing processes by developing and implementing quality control measures, analyzing data, and identifying areas for improvement.

1. Evaluate existing production processes, identify potential issues, and develop strategies to improve quality and efficiency.
2. Implement and maintain quality control processes, ensuring that products meet specified standards and requirements.
3. Collect, analyze, and interpret data related to production processes and quality performance, using statistical tools and techniques.
4. Investigate and resolve quality issues, identifying root causes and implementing corrective actions.
5. Create and maintain documentation related to quality procedures, standards, and training materials.
6. Work closely with other departments, such as manufacturing, engineering, and quality assurance, to ensure quality is integrated into all aspects of production.
7. Support ongoing efforts to improve processes and systems, aiming to reduce defects, improve efficiency, and enhance customer satisfaction.
8. Ensure processes and products comply with relevant industry standards and regulations.
9. Investigate problems during production to determine causes and implement corrective actions.

Duties & Responsibilities:

• Ensure all products, processes, and components are within specifications under the direction of the Quality Manager.
• Participate in cross-functional teams supporting new product development, production, design changes, risk management, and compliance projects.
• Ensure compliance with applicable standards such as 21 CFR 820 and ISO 13485:2016.
• Lead investigations into nonconformance reports (NCR) and CAPA processes.
• Drive manufacturing and quality system improvements.
• Manage customer feedback processes and investigations.
• Author Change Orders (CO) to support procedure and process updates and assist with their implementation.
• Utilize engineering and technical expertise to ensure standards compliance.

Education and Experience:

• Bachelor's Degree in Mechanical, Manufacturing, or Industrial Engineering, or equivalent experience with an Associates degree.
• 3 to 5+ years of experience in an ISO9001, AS9100, or ISO13485 manufacturing environment.
• Experience with statistical data analysis using Minitab or similar tools.
• Ability to lead meetings and present to peers and senior management.
• Knowledge of CAPAs, root cause analysis, and the 8D method.
• Excellent communication skills, both verbal and written.
• High attention to detail and accuracy.
• Ability to manage multiple priorities effectively.