Global QA & Compliance Lead — Complaints & Investigations

MSD; Rahway (NJ); Híbrido; USD 142.000 - 224.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Long-term incentive

Comprehensive benefits

Descripción de la vacante

MSD is seeking an Associate Director of Quality Assurance to guide complaint management and regulatory reporting for MDCP products. This role ensures compliance with worldwide medical device and MDCP regulatory expectations across sites and partners.

You will provide SME input on QA policy, collaborate with Global Safety and Manufacturing, and drive continuous improvement in investigations, tooling, and documentation in a fast-paced, matrix environment.

Formación

• Bachelor’s degree in Science, Engineering, or related field with extensive regulatory/quality experience.
• Experience with medical device regulations (21 CFR 820, EU MDR) and ISO 13485 standards.
• Proven leadership in cross-functional teams and regulatory interactions.

Responsabilidades

• Oversee complaint management and health authority reporting for MDCPs.
• Provide SME guidance on QA processes and regulatory expectations.
• Lead cross-functional teams to improve PQC and AE investigation processes.
• Support internal/external partners and regulatory authorities as needed.

Conocimientos

Adaptability

Complaints Investigation

Creative Thinking

Cross-Functional Teamwork

Medical Device Regulations

Problem Resolution

Working Independently

Educación

Bachelor's in Science/Engineering

Master's in Science/Engineering

Ph.D. in Science/Engineering

Descripción del empleo

MSD is seeking an Associate Director of Quality Assurance to guide complaint management and regulatory reporting for MDCP products. This role ensures compliance with worldwide medical device and MDCP regulatory expectations across sites and partners.

You will provide SME input on QA policy, collaborate with Global Safety and Manufacturing, and drive continuous improvement in investigations, tooling, and documentation in a fast-paced, matrix environment.