Job Information
J&J Family of Companies Quality & Compliance Specialist in West Chester, Pennsylvania
Quality & Compliance Specialist - 2406209059W
Description
US Med Tech Commercial Quality is recruiting for a Quality & Compliance (Q&C) Specialist to support US Orthopedics Last Mile Commercial Operations, to be located in either California, Washington State, Oregon, Colorado, Arizona or Nevada . Remote work options may be considered on a case-by-case basis and if approved by the company.
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 https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the worlds most pressing healthcare challenges. We know that the success of our business and our ability to deliver meaningful solutions depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.
The US MT Commercial Quality Specialist is responsible for the development, execution and oversight of Q&C programs for the Med Tech local operating companies in the US. This includes but is not limited to Internal and External Orthopedic Loaner Distribution Points in the United States. This position will focus on compliance of last mile operations that handle and deliver surgical loaner sets to support joint reconstruction and other 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 Med Tech business objectives, Enterprise Quality Standards, and applicable regulations, while considering the customer experience.
Key Responsibilities:
Establish relationships with DePuy Synthes Sales, Sales Agents, Commercial Operations, J&J DELIVER and Med Tech Franchise customers to solve problems and meet changing operations and regulatory environments.
Define, implement, and validate quality system requirements and systems to meet departmental and business strategies.
Mentor functional partners in the areas of GxP requirements.
Implement and improve systems/processes with focus on; Customer and Commercial quality, Inspection readiness, Quality planning, Nonconformance and corrective action plan development, implementation and effectiveness monitoring.
Provide quality support for existing and new distribution models & processes in the US.
Guide the Operations on the development of standard operating procedures.
Serve as single point of contact for assigned business partners.
Participate in and lead audits, inspections, investigations, and remediation activities.
Qualifications
Education:
High School Diploma required. Associates or higher degree in Regulatory Compliance or Scientific field is preferred.
Experience and Skills:
Required:
Zero to two (0-2) years of related work experience.
Proven experience in a regulated healthcare industry.
Experience in a fast paced, complex operation.
Ability to collaborate and communicate concepts in a way that is easily understood.
Self-directed with flexibility to work independently and on teams.
Time and project management skills.
Strong problem solving, root cause analysis and analytical experience.
Knowledge of applicable FDA regulations and ISO-13485 standards.
Preferred:
Experience interacting with Health Authority or Notified Body is helpful.
Supplier quality management experience.
Other:
Up to 25% domestic travel is required.
The anticipated base pay range for this position is $61,000 to $97,750.
The anticipated base pay range for this position, in the Bay Area, is $71,000 to $112,412
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Companys long-term incentive program.
Employees are eligible for the following time off benefits:
Vacation up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year
Holiday pay, including Floating Holidays up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to:
_https://www.careers.jnj.com/employee-benefits_
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location NA-US-Pennsylvania-West Chester
Other Locations NA-US-Arizona, NA-US-Oregon, NA-US-California, NA-US-Washington, NA-US-Nevada, NA-US-Colorado
Organization Johnson & Johnson Health Care Systems Inc. (6077)
Relocation Eligible: No
Travel Yes, 25 % of the Time
Job Function Quality Assurance
Req ID: 2406209059W