Commercial Quality Compliance Specialist

Accountabilities:

• • 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.

  Requirements:

  • 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.

  Benefits:

  • 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.