Commercial Quality Compliance Specialist in New York at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Commercial Quality Compliance Specialist based in United States.

This fully remote role supports commercial quality and compliance activities across a complex, regulated healthcare environment.
You will help develop, execute, and oversee quality programs supporting distribution centers, loaner distribution points, and field inventory operations.
The position plays a key role in ensuring quality issues are identified, investigated, and resolved efficiently across the commercial supply chain.
You will collaborate closely with Quality, Sales, Commercial Operations, and Supply Chain stakeholders to strengthen compliance and operational performance.
The role may also support the last-mile delivery of surgical loaner sets to orthopedic customers across the United States.
It offers an opportunity to influence quality standards, customer experience, and continuous improvement within a fast-paced healthcare organization.
Success in this position requires strong regulatory knowledge, analytical thinking, communication skills, and the ability to work independently across complex operations.

• Develop, execute, and oversee Quality and Compliance programs supporting commercial operations, distribution centers, loaner distribution points, and field inventory activities across the United States.
• Support quality oversight related to the last-mile delivery of surgical loaner sets and help ensure products and services meet applicable quality and compliance expectations.
• Act as a liaison between Quality, Sales, Commercial Operations, Supply Chain, and other business partners on commercial and distribution quality matters.
• Investigate and drive timely resolution of quality issues using structured problem-solving and root-cause analysis approaches.
• Identify, assess, and support the implementation of practical quality and compliance improvements aligned with business objectives, quality standards, regulatory requirements, and customer needs.
• Contribute to quality oversight of internal and external inventory and distribution partners, including opportunities to strengthen supplier and operational quality performance.
• Support compliance with applicable regulatory requirements and quality standards while maintaining a strong focus on customer experience and operational effectiveness.

• Bachelor’s degree in regulatory compliance, science, engineering, or a related field, plus at least 2 years of experience in a regulated healthcare industry; alternatively, an associate degree with a minimum of 5 years of relevant regulated healthcare experience.
• Demonstrated experience working within a regulated healthcare environment and a fast-paced, complex operation.
• Working knowledge of applicable FDA regulations and ISO 13485 standards.
• Strong problem-solving, analytical, and root-cause analysis capabilities.
• Proven ability to manage projects, priorities, timelines, and competing responsibilities effectively.
• Ability to work independently with limited supervision while collaborating effectively within cross-functional teams.
• Strong communication and interpersonal skills, with the ability to explain technical and compliance concepts clearly to diverse stakeholders.
• Supplier Quality Management experience is preferred.
• Experience interacting with health authorities or notified bodies is preferred.
• A proactive, adaptable, and customer-focused approach to quality and compliance challenges.

• Anticipated base salary range of $79,000–$127,650.
• Fully remote work arrangement within the United States, with listed locations including Raynham, Massachusetts, and West Chester, Pennsylvania.
• Eligibility to participate in a retirement pension plan and 401(k) savings plan, subject to applicable plan terms.
• Eligibility for a long-term incentive program.
• 120 hours of vacation per calendar year, subject to applicable policies and date of hire.
• 40 hours of sick time per calendar year, with enhanced allowances in certain states.
• 13 paid holidays, including floating holidays.
• Up to 40 hours of Work, Personal and Family Time per calendar year.
• 480 hours of parental leave within one year following the birth, adoption, or foster care of a child.
• Bereavement, caregiver, volunteer, and military spouse time-off programs, subject to applicable policies and eligibility requirements.
• An inclusive work environment with accommodations available to support candidates and employees with disabilities.