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 Donatelles 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.

Qualifications

- 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

Qualifications

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