Commercial Quality Compliance Specialist

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

📋 Description

• Develop, implement, and manage Quality and Compliance initiatives for DePuy Synthes Sales Inc.

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

• Focus on the last-mile delivery of surgical loaner sets to orthopedic customers nationwide.

• Collaborate with Franchise Quality, Sales, Commercial Operations, and Supply Chain stakeholders.

• Ensure prompt resolution of quality-related issues in commercial and distribution processes.

• Identify and facilitate the execution of opportunities for quality and compliance enhancements.

• Align improvements with business goals, Quality Standards, relevant regulations, and customer satisfaction.

⛳️ 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 FDA regulations and ISO-13485 standards.

• Self-motivated with the ability to work autonomously as well as collaboratively in teams.

• Strong capability to communicate and convey concepts effectively.

• Demonstrated skills in time and project management.

• Excellent problem-solving abilities, including root cause analysis and analytical skills.

• Proven background in a regulated healthcare field.

• Experience in a dynamic and complex operational environment.

• Supplier quality management experience is preferred.

• Interaction experience with a Health Authority or notified body is preferred.

• Preferred background in Supplier Quality.

🏝️ Benefits

• Pension plan.

• Savings plan (401(k)).

• Long-term incentive program.

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; Colorado residents – 48 hours; Washington residents – 56 hours.

• 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.

• Inclusive interview accommodations.

• Fully remote work arrangement.