Quality Systems Engineer

The Quality Systems Engineer will work in conjunction with the Quality Manager to establish and maintain SPG's Quality Management System Manual, ensuring its content is aligned with regulatory requirements, business plan strategic objectives, and customer expectations. The role involves leading and driving timely completion of CAPAs derived from audits, maintaining awareness of laws and regulations, and providing guidance and advice on methods, procedures, and requirements.

What You Will Do

Responsibilities include leading and driving timely completion of CAPAs, maintaining awareness of laws and regulations, conducting and managing the SOP Employee Training Data Base, and providing material purity information to customers. The role also involves coordinating, facilitating, and following up on internal, customer, and supplier audits, and assisting in the creation of Management Review reports.

Why It Might Be a Fit

The ideal candidate will have a thorough understanding and working knowledge of ISO 13485:2016 and/or AS9100D:2016 standards, experience managing third-party regulatory and customer audits, and strong communication, presentation, and analytical skills.

Requirements

• Degree of Science or Business or similar
• 3-5 years' experience in Quality Assurance in a manufacturing environment
• Certified Lead Auditor
• Experience managing third-party regulatory and customer audits
• Basic understanding of manufacturing processes and operation systems
• Strong communication, presentation, and analytical skills
• Ability to negotiate and communicate successfully at all levels
• Working knowledge of computers, software applications (at least: Word, Excel, Visio, Access, and Outlook), and excellent reading/comprehension skills