Senior Quality Systems Lead - SAP & Compliance

Planet Pharma; Tempe (AZ); On-site; USD 84,000 - 103,000; Full time

Job summary

The Senior Quality Systems Specialist at Planet Pharma will serve as the primary interface between the company and external customers for a designated business, owning and optimizing the QMS processes that support customer-related activities in a regulated environment.

Responsibilities include managing orders, changes, complaints, RMAs, and cross-functional coordination to ensure ISO 13485 and FDA compliance, audit readiness, and accurate documentation across SAP and MES systems.

Qualifications

• Customer-facing quality systems experience in a regulated environment.
• SAP-based order and shipment execution.
• Experience with customer complaints, RMAs, and cross-functional coordination.

Responsibilities

• Own and optimize the QMS processes supporting customer activities.
• Manage orders, changes, complaints, and RMAs.
• Develop and track metrics for customer-related quality processes.
• Ensure audit readiness for customer-related quality processes.
• Coordinate with cross-functional teams for root-cause analysis and improvements.
• Serve as primary interface between customers and internal teams.

Skills

Quality systems experience

SAP

Customer complaints/RMA coordination

Education

Bachelor's degree

Tools

SAP (ERP)

MES

QMS software

Job description

The Senior Quality Systems Specialist at Planet Pharma will serve as the primary interface between the company and external customers for a designated business, owning and optimizing the QMS processes that support customer-related activities in a regulated environment.

Responsibilities include managing orders, changes, complaints, RMAs, and cross-functional coordination to ensure ISO 13485 and FDA compliance, audit readiness, and accurate documentation across SAP and MES systems.