Quality Documentation & Compliance Specialist

Medline Industries, LP; Mundelein (IL); Sur place; USD 67 000 - 101 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) contributions

Paid time off

Résumé du poste

Medline Industries, LP in Mundelein, IL is seeking a Quality professional focused on a subsection of our Quality Management System (QMS) such as device master records, customer complaints, or recalls. You will help build and maintain product specifications, tolerances, drawings, inspection criteria and testing reports, supporting compliance with FDA and ISO standards.

The ideal candidate has a bachelor’s degree in a related field and at least two years in quality, with strong MS Office skills

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field.
• 2+ years of experience in Quality.
• Proficient in MS Office with Excel; understands 21 CFR 820 and ISO 13485.

Responsabilités

• Develop and implement processes, reports, data analysis and procedures within the defined area of specialization.
• Collaborate with internal and external groups to maintain FDA/ISO compliance.
• Facilitate meetings with global units to manage project requirements and deadlines.
• Review documentation for completeness and accuracy to meet specifications.

Connaissances

MS Office

Excel (intermediate)

Quality systems knowledge

FDA/ISO standards

Travel

Formation

Bachelor’s in Engineering/Science

Outils

MS Office Suite

Description du poste

Medline Industries, LP in Mundelein, IL is seeking a Quality professional focused on a subsection of our Quality Management System (QMS) such as device master records, customer complaints, or recalls. You will help build and maintain product specifications, tolerances, drawings, inspection criteria and testing reports, supporting compliance with FDA and ISO standards.

The ideal candidate has a bachelor’s degree in a related field and at least two years in quality, with strong MS Office skills