Director of Quality – Compliance

The O'Connor Group

Director of Quality & Compliance at Active Protective Technologies ensuring FDA compliance for medical devices. Leading quality management systems and overseeing regulatory affairs with a collaborative team environment.

Posted 7/10/2026full-timeConshohocken • Pennsylvania • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

Maintain compliance with U.S. Food & Drug Administration requirements
Oversee the Quality Management System in accordance with ISO 13485 and FDA Quality System Regulation (21 CFR 820)
Work cross-functionally to ensure Durable Medical Equipment (DME) program compliance
Ensure compliance with HIPAA requirements
Provide a safe, secure, work environment in compliance with OSHA, Medicare and FDA standards
Directly oversee legal and government affairs operations
Establish, monitor, and improve work processes

Requirements

What you’ll need

Bachelor’s degree in engineering or scientific discipline
Minimum of 10 years of experience in an FDA or CMS regulated space
Strong communication skills, both written and verbal
Strong ability to work collaboratively and cross-functionally
Strong organizational skills
Strong attention to detail
Strong knowledge of FDA requirements and quality management principles (ISO 13485)
Strong knowledge of Medicare Durable Medical Equipment requirements
Proficiency with relevant software (e.g. eQMS, word processing, etc.)

Benefits

Comp & perks

Health & Safety Program Compliance
Continuous Improvement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management PrinciplesRegulatory ComplianceProcess ImprovementAttention to DetailOrganizational Skills

Soft Skills

Strong Communication SkillsCollaborative Work Ability