Commercial Quality Compliance Specialist

This is a fully remote position, open to applicants in Massachusetts, +1 more state.

📋 Description

• Design, implement, and manage Quality and Compliance programs for DePuy Synthes Sales Inc.

• Provide support to Distribution Centers, Loaner Distribution Points, and Field Inventory Managers throughout the United States.

• Concentrate on the “last mile” delivery of surgical loaner sets that assist orthopedic customers nationwide.

• Act as a liaison among Franchise Quality, Sales, Commercial Operations, and Supply Chain partners.

• Facilitate prompt resolution of quality-related issues in commercial and distribution settings.

• Recognize and aid in the implementation of effective quality and compliance enhancements.

• Ensure that improvements align with business goals, Quality Standards, relevant regulations, and customer experiences.

⛳️ Requirements

• Bachelor’s Degree in regulatory compliance, science, or engineering with a minimum of 2 years of experience in a regulated healthcare environment, OR an Associate degree with at least 5 years of experience in a regulated healthcare setting.

• Familiarity with relevant FDA regulations and ISO-13485 standards.

• Self-motivated, demonstrating the ability to work independently as well as collaboratively in teams.

• Capable of conveying concepts clearly and understandably.

• Demonstrated skills in time and project management.

• Strong abilities in problem-solving, root cause analysis, and analytical thinking.

• Proven background in a regulated healthcare environment.

• Experience in a dynamic and complex operational setting.

• Supplier quality management experience is preferred.

• Experience with Health Authority or notified body interactions is preferred.

• Background in Supplier Quality is preferred.

🏝️ Benefits

• Consolidated retirement plan (pension).

• Savings plan (401(k)).

• Long-term incentive program.

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; 48 hours for employees in Colorado; 56 hours for employees in Washington.

• Holiday pay, including Floating Holidays – 13 days per calendar year.

• Work, Personal and Family Time – up to 40 hours per calendar year.

• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.

• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.

• Caregiver Leave – 80 hours in a 52-week rolling period.

• Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.