Program Manager, Quality and Compliance (Medtech)

TL;DR

Program Manager, Quality and Compliance (Medtech): Managing product data and global ship hold/field action processes with an accent on SAP data extraction, validation, and regulatory compliance. Focus on optimizing product data flow, leading cross-functional projects to resolve data issues, and ensuring adherence to ISO standards and Quality Management Systems.

Location: Remote (US)

Salary: $160k - $180k

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Serve as the global subject matter expert for product ship hold and field action processes.
• Extract, analyze, and validate product data from SAP to support audits, investigations, and quality activities.
• Lead cross-functional project teams to identify and implement solutions for product data issues.
• Collaborate with regulatory, quality, manufacturing, and customer service teams to ensure accurate data flow.
• Develop and review departmental procedures, work instructions, and guidance templates.
• Maintain knowledge of SAP functionality and best practices to optimize company processes.

Requirements

• Bachelor’s degree in a scientific, technical, or information-based discipline.
• Minimum 6 years of experience in a technical or data-focused role using SAP as a core system.
• Must be based in the United States.
• Experience with post-market quality activities, including recalls, field actions, CAPA, and complaint handling.
• Advanced knowledge of Quality Management Systems (QMS), ISO standards, and regulatory management controls.
• Proficiency with Microsoft Office Suite.

Nice to have

• Experience in the medical device or pharmaceutical industry.
• Three or more years of experience specifically with field actions and product holds.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance.
• 401k plan with company match.
• Paid Time Off and Wellness initiatives.
• Parental and Caregiver Leave.
• Tuition Reimbursement.
• Fully remote work arrangement (5 days at home).