Quality Systems Engineer

KEY RESPONSIBILITIES:

1. 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.
2. 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.
3. Maintain awareness of laws and regulations, keeping abreast of current changes that may affect organization.
4. Leads and drives timely completion of CAPAs derived from audits
5. Aid in oversight for Customer Complaints, CAPA, MRB Dispositions, and Documentation Control System.
6. Responsible for coordination, facilitation, and follow-up for internal, customer, and supplier audits in conjunction with the Quality Manager.
7. Assist in the creation of Management Review reports.
8. Conduct, manage and maintain the SOP Employee Training Data Base providing the training documents required for ISO compliance and ensuring timely employee training required.
9. Responsible for obtaining, reviewing, and providing material purity information to customers.
10. Provides guidance and advice on methods, procedures, standardization and requirements.
11. Other duties as assigned.

Qualifications

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

EXPERIENCE, SKILLS, EDUCATION AND TRAINING:

ISO Certification: 2 years (Preferred)

Quality Assurance: 3 years (Preferred)

Manufacturing: 3 years (Preferred)

Education

Degree of Science or Business or similar