Hybrid Quality Systems & Compliance Specialist

Merck; Upper Gwynedd Township (Montgomery County); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Merck is seeking a Specialist, Quality Systems & Compliance within Device Regulatory & Quality. The role supports the MDCP Complaints team, reviews documentation for compliance with medical device regulations, and assists in MDCP projects across IT systems like SAP and Veeva Vaults.

You will collaborate with cross-functional teams, perform data maintenance, and ensure appropriate CAPAs and deviations are tracked.

Qualifications

• Bachelor’s degree in Science, Engineering, Health Care, STEM or related technical field.
• 1–3 years in Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products.

Responsibilities

• Review external customer complaints for health authority submission suitability.
• Document review/approval in complaint database.
• Collaborate with Site Complaint Investigating Unit to ensure root causes are addressed.

Skills

Adaptability

Teamwork

Independent work

Communication

Education

Bachelor's degree in Science/Engineering/Health Care/STEM

Tools

SAP ECC

SAP PLM

Veeva Quality & Regulatory Vaults

Job description

Merck is seeking a Specialist, Quality Systems & Compliance within Device Regulatory & Quality. The role supports the MDCP Complaints team, reviews documentation for compliance with medical device regulations, and assists in MDCP projects across IT systems like SAP and Veeva Vaults.

You will collaborate with cross-functional teams, perform data maintenance, and ensure appropriate CAPAs and deviations are tracked.