Hybrid QMS & Compliance Specialist - Medical Devices

Merck & Co.; Rahway (NJ); Ibrido; USD 87.000 - 137.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays and vacation

Descrizione del lavoro

Merck & Co. in Rahway, NJ seeks a Specialist, Quality Systems & Compliance within Device Regulatory & Quality to support the MDCP Complaints team and cross-functional sites.

You will review documentation for compliance with medical device regulations and internal requirements, and execute MDCP projects across the device data domain. Key duties include reviewing external complaint investigations, maintaining SAP master data, supporting CAPAs and deviations, and ensuring robust corrective actions.

Competenze

• 1-3 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products; or related fields.
• Required: Bachelor's degree in Science, Engineering, Health Care, STEM or related technical field

Mansioni

• Review reportable external customer complaints, upon intake, for appropriateness for health authority submission
• Document review/approval in complaint database
• Collaborate with Site Complaint Investigating Unit and Device -Technical Operations to ensure robust corrective and/or preventive actions are put in place
• Review the Device Risk Management Files to ensure the customer complaint being investigated is appropriately represented
• Collaborate with Device to update the Device Risk Management files, as needed.
• Review and approve reportable external customer complaint investigation reports prior to their submission to health authority
• Assist with maintenance of MDCP data across our company's IT systems, including but not limited to SAP ECC, SAP PLM, and Veeva Quality and Regulatory Vaults
• Maintains SAP access and role mapping for Device Quality & Regulatory Complaints team

Conoscenze

Adaptability

Complaints Investigation

Creative Thinking

Cross-Functional Teamwork

Detail-Oriented

Problem Solving

Working Independently

Formazione

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

Strumenti

SAP ECC

SAP PLM

Veeva Quality

Descrizione del lavoro

Merck & Co. in Rahway, NJ seeks a Specialist, Quality Systems & Compliance within Device Regulatory & Quality to support the MDCP Complaints team and cross-functional sites.

You will review documentation for compliance with medical device regulations and internal requirements, and execute MDCP projects across the device data domain. Key duties include reviewing external complaint investigations, maintaining SAP master data, supporting CAPAs and deviations, and ensuring robust corrective actions.