Senior Quality Systems Engineer & Audit Expert

DuPont™ Spectrum™; Minneapolis (MN); On-site; USD 80,000 - 110,000; Full time

Job summary

DuPont™ Spectrum™ is seeking a Quality Assurance professional to establish and maintain the Quality Management System Manual in alignment with regulatory and customer requirements. The role also serves as Management Representative in the absence of the Quality Manager, overseeing regulatory affairs and customer quality needs.

The candidate should hold a Science or Business degree with 3–5 years in QA in manufacturing, possess ISO 13485:2016 and/or AS9100D:2016 knowledge, and be a certified Lead

Qualifications

• Must possess degree of Science or Business or similar, with 3-5 years’ experience in Quality Assurance in a manufacturing environment.
• Thorough understanding of ISO 13485:2016 and/or AS9100D:2016 standards.
• Certified Lead Auditor.
• Experience managing third party regulatory and customer audits.
• Strong communication, presentation and analytical skills.
• Working knowledge of computers and MS Office applications.

Responsibilities

• Establish and maintain SPG's Quality Management System Manual, ensuring alignment with regulatory requirements, business plan objectives and customer expectations.
• In the absence of the Quality Manager, act as Management Representative for quality, regulatory affairs and customer quality requirements.
• Lead and drive timely completion of CAPAs from audits.
• Coordinate and follow-up for internal, customer, and supplier audits.
• Assist in creation of Management Review reports.
• Manage SOP Employee Training Database for ISO compliance and timely training.
• Provide material purity information to customers.
• Offer guidance on methods, procedures, standardization and requirements.

Skills

Quality Assurance

Regulatory compliance

Auditing

Analytical skills

Communication

Lead Auditor

Education

Science or Business degree

Tools

Word

Excel

Visio

Access

Outlook

Job description

DuPont™ Spectrum™ is seeking a Quality Assurance professional to establish and maintain the Quality Management System Manual in alignment with regulatory and customer requirements. The role also serves as Management Representative in the absence of the Quality Manager, overseeing regulatory affairs and customer quality needs.

The candidate should hold a Science or Business degree with 3–5 years in QA in manufacturing, possess ISO 13485:2016 and/or AS9100D:2016 knowledge, and be a certified Lead