at J&J Family of Companies in Dover, Delaware, United States
Job Description
Staff Quality Systems Engineer – (Remote) – 2406202878W
Description
Johnson and Johnson is currently seeking a Staff Quality Systems Engineer to join our team remotely.
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 world’s 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.
JOB SUMMARY
The Staff Quality Systems Engineer has the responsibility for the Abiomed quality system supporting CAPA, data analysis, assurance of robust failure investigation and content, supporting the Center of Excellence, monitoring of CAPA quality system processes, metrics and serving as a coach and advocate for the quality system. The Staff Quality Systems Engineer must also collaborate across Abiomed to support the harmonization and integration of an optimized Abiomed Quality system process.
DUTIES & RESPONSIBILITIES
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- The Staff Quality Systems Engineer will serve as a Quality Systems subject matter expert, track and report action plan status/ completion as relates to failure investigation, root cause investigation and quality systems improvement efforts.
- Provides training regarding Quality Management System Elements (including, but not limited to CAPA, DRB, Management Review, & Metrics) to representatives from other functional areas.
- Facilitates or supports meetings (including, but not limited to CAPA, DRB, Management Review, & Metrics)
- Monitors and reports Quality Management System metrics.
- Works on complex investigations and coordinates technical teams and leads cross functional teams to ensure sound experimental design, effective data analysis, identification, implementation, verification, and validation of CAPA, and subsequent closure of investigations.
- Identifies opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives.
- Supports, participates, and leads in cross-functional projects when assigned/appropriate.
- Provides audit support for 3rd Party Inspections (e.g. Registrar, Notified Body, FDA, or customer audits).
- Completes assessments for internal and external standards and regulations across Abiomed sites
- Processes document changes in applicable document management systems as needed including maintenance of Franchise Quality Manuals and Quality Planning procedures.
- Provide leadership on optimization and harmonization Quality projects across Abiomed.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Performs other duties assigned as needed.
Qualifications
- A BS degree in Engineering, Sciences, or Business Analysis is required.
- Experience working in an FDA regulated environment is required.
- Minimum of 4-6 years of experience working in an Operations, Manufacturing, Quality and/or Engineering role is required.
- Strong communication, human relation, problem solving, and analytical skills are all required.
- Demonstrated skills in root cause analysis and failure investigation are required.
- Experience in dealing with audits/ inspections with the FDA, other notified bodies or any other Health Authority
- Demonstrated Project Management skills with a strong result orientation.
- Ability to communicate effectively with all levels of management and functions is required.
- Strong in ability to build collaboration, partnership, and teamwork across local and global organizations.
- Demonstrated proficiency in problem solving skill sets and good analytical skills.
- Demonstrated leadership skills without direct authority responsibility.
- Demonstrated effectiveness as a team member and a team leader.
- Adaptability for travel, both domestic and international (~10%)
The anticipated base pay range for this position is $105,000 to $166,635.
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 corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s 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 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.
-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 of Work, Personal and Family Time – up to 40 hours per calendar year
Additional information can be found through the link below. 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.
This position is scheduled to close on Sunday August 10, 2024.
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-4887-Danvers
Other Locations NA-United States
Organization ABIOMED Inc.(6942)
Travel Yes, 10 % of the Time
Job Function Quality Systems
Req ID: 2406202878W
