Commercial Quality Compliance Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.comAs guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.Job Function: QualityJob Sub Function: Customer/Commercial QualityJob Category:ProfessionalAll Job Posting Locations:Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of AmericaJob Description:DePuy Synthes is recruiting for a Commercial Quality Specialist located in Raynham, MA, with considerations given to support remotely from the US at the discretion of the business.Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.DePuy Synthes provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to healthcare systems worldwide. For more information, visit DePuy Synthes Commercial Quality Specialist is responsible for the development, execution and oversight of Quality and Compliance (Q&C) programs for the DePuy Synthes Sales Inc. local operating company. This includes but is not limited to Distribution Centers, Loaner Distribution Points and Field Inventory Managers (internal and external) in the United States. This position resides in the DePuy Synthes Commercial Quality Organization.This position may focus on “last mile” delivery of surgical loaner sets supporting orthopedic customers across the US. This position serves as a liaison with Franchise Quality, Sales, Commercial Operations and Supply Chain partners on commercial and distribution quality related matters to drive timely resolution of quality related issues. This position identifies and supports implementation of fit for purpose quality and compliance improvement opportunities consistent with DePuy Synthes business objectives, Quality Standards, and applicable regulations, while considering the customer experience.Key Responsiblities:The DePuy Synthes Commercial Quality Specialist is responsible for the development, execution and oversight of Quality and Compliance (Q&C) programs for the DePuy Synthes Sales Inc. local operating company. This includes but is not limited to Distribution Centers, Loaner Distribution Points and Field Inventory Managers (internal and external) in the United States. This position resides in the DePuy Synthes Commercial Quality Organization.This position may focus on “last mile” delivery of surgical loaner sets supporting orthopedic customers across the US. This position serves as a liaison with Franchise Quality, Sales, Commercial Operations and Supply Chain partners on commercial and distribution quality related matters to drive timely resolution of quality related issues. This position identifies and supports implementation of fit for purpose quality and compliance improvement opportunities consistent with DePuy Synthes business objectives, Quality Standards, and applicable regulations, while considering the customer experience.RequiredBachelor Degree in regulatory compliance or science or engineering with at least 2-years experience in regulated healthcare industry, OR Associates degree with minimum of 5 years of experience in a regulated healthcare industry.The following skills are required:· Knowledge of applicable FDA regulations and ISO-13485 standards.· Self-directed with flexibility to work independently and on teams.· Ability to collaborate and communicate concepts in a way that is easily understood.· Proven time and project management skills.· Strong problem solving, root cause analysis and analytical experience.· Supplier quality management experience preferred.· Proven experience in a regulated healthcare industry.· Experience in a fast paced, complex operation is required.· Experience interacting with Health Authority or notified body is preferred.· Supplier Quality experience is preferred.Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.#LI-RemoteRequired Skills:Preferred Skills:The anticipated base pay range for this position is :$79,000.00 - $127,650.00Additional Description for Pay Transparency:Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Company’s long-term incentive program.Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:Vacation –120 hours per calendar yearSick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - Raynham, Massachusetts, United States of America; West Chester, Pennsylvania, United States of AmericaType: Full time