Quality Engineer, Medical Devices | SPC, CAPA & CE Compliance

Medline Industries, Inc.; Norristown (Montgomery County); Sur place; USD 79 000 - 119 000; Plein temps

Avantages offerts par ce poste

Health insurance

Life and disability

401(k) contributions

Paid time off

Employee Assistance Program

Employee Resource Groups

Employee Service Corp

Résumé du poste

Medline Industries, LP in Norristown, PA is seeking a Quality Engineer to independently set basic quality standards for in-process work and lead methods for testing, sampling and training. You will drive process improvements, perform SPC-based analyses, and collaborate with suppliers on CAPA and supplier qualifications.

Responsibilities include building compliant device master records and CE/510K documentation with Regulatory teams, and conducting design control activities.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• Minimum 2 years in Quality or Engineering.
• Knowledge of 21 CFR 820 and ISO13485.
• Ability to travel up to 15%.

Responsabilités

• Develop and implement methods for process control, validation, and inspection to ensure product quality.
• Design experiments and apply SPC to analyze data and guide changes.
• Lead supplier qualifications and CAPA activities.
• Prepare and maintain design history records and 510K-related documents.
• Investigate non-conformances and implement CAPA.

Connaissances

Independence

Time management

Problem solving

MS Office

Excel advanced

Quality standards

Travel 15%

Formation

Bachelor's degree in Engineering/Science/Math

Outils

MS Office Suite

Description du poste

Medline Industries, LP in Norristown, PA is seeking a Quality Engineer to independently set basic quality standards for in-process work and lead methods for testing, sampling and training. You will drive process improvements, perform SPC-based analyses, and collaborate with suppliers on CAPA and supplier qualifications.

Responsibilities include building compliant device master records and CE/510K documentation with Regulatory teams, and conducting design control activities.