Senior Quality Engineer – Medical Devices & CAPA Leader

Regulatory Jobs; Town of Hartland (WI); Sur place; USD 101 000 - 152 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) contributions

Paid time off

Résumé du poste

Medline Industries, LP is seeking a Quality/Regulatory Engineer to establish basic quality standards and lead testing, sampling and training efforts. You will develop methods for process control, vendor management, and submission-ready documentation including DMRs and CE files.

The role involves designing experiments, applying SPC, and guiding CAPA actions to reduce defects while ensuring compliance with 21 CFR and ISO standards. Travel up to 15% may be required.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 4 years of experience in Quality or Engineering.
• Experience with government and industry quality codes (e.g., 21 CFR 820, ISO13485, 21 CFR 210/211, MDD/MDR, ANSI/AAMI/ISO).
• Preferred Six Sigma/Lean knowledge; 5+ years in medical devices or related fields.

Responsabilités

• Develop and implement methods and procedures for process control, validation, testing and inspection.
• Design experiments using SPC to understand variation and evaluate changes.
• Conduct product testing, analyze results, and lead CAPA actions.
• Collaborate with suppliers on quality issues and lead supplier qualifications.
• Provide quality input in design control, risk management, and CE files; prepare DMRs.
• Ensure compliance with domestic and international regulations; review design docs.
• Lead investigations into non-conformances and prevent recurrence.
• Coach team members on best practices; act as Quality lead when needed.

Connaissances

Quality assurance

SPC methods

Team leadership

Vendor management

CAPA/SCAR

Regulatory knowledge

MS Office

Excel advanced

Formation

Bachelor’s degree in Engineering/Science

Outils

Microsoft Excel

Description du poste

Medline Industries, LP is seeking a Quality/Regulatory Engineer to establish basic quality standards and lead testing, sampling and training efforts. You will develop methods for process control, vendor management, and submission-ready documentation including DMRs and CE files.

The role involves designing experiments, applying SPC, and guiding CAPA actions to reduce defects while ensuring compliance with 21 CFR and ISO standards. Travel up to 15% may be required.