Quality Systems Engineer

Key Responsibilities

• Establish and maintain SPG's Quality Management System Manual, aligning it with regulatory requirements, business plan strategic objectives, and customer expectations.
• In the absence of the Quality Manager, act as Donatelle’s Management Representative in quality management system, regulatory affairs, compliance, and customer quality requirements.
• Maintain awareness of laws and regulations, staying updated on changes that may affect the organization.
• Lead and drive the timely completion of Corrective and Preventative Action (CAPA) plans derived from audits.
• Aid in overseeing Customer Complaints, CAPA, Material Review Board (MRB) Dispositions, and Documentation Control System.
• Coordinate, facilitate, and follow up for internal, customer, and supplier audits in conjunction with the Quality Manager.
• Create and provide Management Review reports.
• Conduct, manage, and maintain the SOP Employee Training Database, ensuring ISO compliance and timely employee training.
• Obtain, review, and provide material purity information to customers.
• Provide guidance and advice on methods, procedures, standardization, and requirements.

Qualifications

• Must possess a degree in Science, Business, or a similar field, with 3-5 years of experience in Quality Assurance in a manufacturing environment.
• Must have a thorough understanding and working knowledge of ISO 13485:2016 and/or AS9100D:2016 standards.
• Must be a certified Lead Auditor.
• Must have experience managing third-party regulatory and customer audits.
• Must have a basic understanding of manufacturing processes and operation systems.
• Must possess strong communication, presentation, and analytical skills.
• Must have the ability to negotiate and communicate effectively at all levels.
• Must have working knowledge of computers, software applications (Word, Excel, Visio, Access, and Outlook), and excellent reading and comprehension skills.