Quality Systems Engineer
About The Position
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 aligns with regulatory requirements, business plan strategic objectives, and customer expectations. In the absence of the Quality Manager, this role acts as Donatelle’s Management Representative for all matters concerning the quality management system, regulatory affairs, compliance, and customer quality requirements. The position requires maintaining awareness of current laws and regulations that may affect the organization, leading timely completion of CAPAs from audits, and aiding in oversight for Customer Complaints, CAPA, MRB Dispositions, and the Documentation Control System. Responsibilities include coordinating, facilitating, and following up on internal, customer, and supplier audits, assisting in the creation of Management Review reports, and managing the SOP Employee Training Data Base to ensure ISO compliance. The role is also responsible for obtaining, reviewing, and providing material purity information to customers, and providing guidance on methods, procedures, standardization, and requirements. Other duties as assigned.
Requirements
- Degree of Science or Business or similar.
- 3-5 years of experience in Quality Assurance in a manufacturing environment.
- Thorough understanding and working knowledge of ISO 13485:2016 and/or AS9100D:2016 standards.
- 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 and software applications (Word, Excel, Visio, Access, and Outlook).
- Excellent reading/comprehension skills.
Nice To Haves
- ISO Certification: 2 years
- Quality Assurance: 3 years
- Manufacturing: 3 years
Responsibilities
- Establish and maintain SPG's Quality Management System Manual in alignment with regulatory requirements, business plan strategic objectives, and customer expectations.
- Act as Donatelle’s Management Representative in the absence of the Quality Manager for quality management system, regulatory affairs, compliance, and customer quality requirements.
- Maintain awareness of current laws and regulations affecting the organization.
- Lead and drive timely completion of CAPAs derived from audits.
- Aid in oversight for Customer Complaints, CAPA, MRB Dispositions, and Documentation Control System.
- Coordinate, facilitate, and follow up for internal, customer, and supplier audits.
- Assist in the creation of Management Review reports.
- Conduct, manage, and maintain the SOP Employee Training Data Base, providing necessary training documents for ISO compliance and ensuring timely employee training.
- Obtain, review, and provide material purity information to customers.
- Provide guidance and advice on methods, procedures, standardization, and requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
