Commercial Quality Compliance Specialist

📋 Description

• Develop, execute, and oversee quality and compliance programs for commercial ops, DCs, loaner
• Support quality oversight of last-mile delivery of surgical loaner sets.
• Act as liaison between Quality, Sales, Commercial Ops, and Supply Chain on quality matters.
• Investigate quality issues using structured problem-solving and root-cause analysis.
• Identify and implement practical quality/compliance improvements aligned with regs and customer
• Contribute to quality oversight of inventory and distribution partners to improve supplier quality.

🎯 Requirements

• Bachelor’s in regulatory compliance, science, engineering, or related field, plus 2+ years in
• Experience in a regulated healthcare environment and fast-paced operations.
• Working knowledge of FDA regulations and ISO 13485.
• Strong problem-solving, analytical, and root-cause skills.
• Project and priority management with limited supervision and cross-functional collaboration.
• Strong communication to explain technical/compliance concepts to diverse stakeholders.

🎁 Benefits

• Anticipated base salary range of $79,000–$127,650.
• Fully remote work in the United States (locations include Raynham, MA, and West Chester, PA).
• Eligibility for retirement plan and 401(k).
• Eligibility for long-term incentive program.
• 120 hours vacation per year.
• 40 hours sick time per year, with state variations.