Quality Systems Engineer

KEY RESPONSIBILITIES

• Working in conjunction with the Quality Manager, establish and maintain SPG's Quality Management System Manual, ensuring its content is aligned with regulatory requirements, business plan strategic objectives and customer expectations.
• In the absence of the Quality Manager, act as Donatelle’s Management Representative in all matters concerning the quality management system, regulatory affairs and compliance, and customer quality requirements.
• Maintain awareness of laws and regulations, keeping abreast of current changes that may affect organization.
• Leads and drives timely completion of CAPAs derived from audits
• Aid in oversight for Customer Complaints, CAPA, MRB Dispositions, and Documentation Control System.
• Responsible for coordination, facilitation, and follow-up for internal, customer, and supplier audits in conjunction with the Quality Manager.
• Assist in the creation of Management Review reports.
• Conduct, manage and maintain the SOP Employee Training Data Base providing the training documents required for ISO compliance and ensuring timely employee training required.
• Responsible for obtaining, reviewing, and providing material purity information to customers.
• Provides guidance and advice on methods, procedures, standardization and requirements.
• Other duties as assigned.

• Must possess degree of Science or Business or similar, with 3-5 years’ 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 basic understanding of manufacturing processes and operation systems
• Must possess strong communication, presentation and analytical skills
• Must have ability to negotiate and communicate successfully at all levels
• Must possess working knowledge of computers, software applications (at least: Word, Excel, Visio, Access and Outlook) and excellent reading/comprehension skills

• ISO Certification: 2 years (Preferred)
• Quality Assurance: 3 years (Preferred)
• Manufacturing: 3 years (Preferred)

• Degree of Science or Business or similar