Quality Systems Engineer

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.com As 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: Quality Job Sub Function: Quality Systems Job Category: Professional All Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: Position Overview We are currently accepting applications for the role of Quality System Engineer. The successful candidate will be tasked with developing, implementing, and maintaining quality management systems to ensure compliance with industry standards and regulatory requirements. This position will require collaboration with cross-functional teams to identify opportunities for improvement, and promote continuous improvement initiatives throughout the organization. Key Responsibilities Design and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed. Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards. Conduct internal and external audits, and support the implementation of corrective and preventive actions to address identified issues. Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team. Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments. Design and oversee quality processes and documentation to ensure accurate and consistent procedures are followed. Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards. Participate in internal and external audits, and support the implementation of corrective and preventive actions to address identified issues. Manage and track Corrective and Preventive Actions (CAPA) and Non-Conformances (NC), ensuring timely resolution and documentation in accordance with regulatory requirements. Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team. Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments Qualifications Bachelor’s degree in engineering, Quality Management, or a related field. At least three years of experience working with quality systems in a regulated industry. Comprehensive understanding of ISO, FDA, or other applicable standards. Strong analytical, problem-solving, and communication skills. Certification in quality management, such as Six Sigma or CQE, is preferred. Required Skills: Preferred Skills: Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaborating, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People The anticipated base pay range for this position is : $79,000.00 - $127,650.00 Additional Description for Pay Transparency: 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 year Sick 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 year 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 period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - 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 Do Not Sell or Share My Personal Information Limit the Use of My Personal Information