Quality Systems Engineer
About The Position
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 Job Function: Quality Job Sub Function: Quality Systems Job Category: Professional All Job Posting Locations: Raynham, Massachusetts, United States of America Job Description: Job summary: Support and drive continuous improvement of the quality management system across MedTech entities under moderate supervision. Develop and track quality-systems metrics and implement quality programs aligned with enterprise and segment standardization initiatives. Provide coaching and training on quality-systems topics to ensure consistent execution across assigned entities.
Requirements
- Bachelor’s degree in engineering, a scientific discipline, or related technical/quality field (or equivalent).
- Minimum of 2 years relevant work experience.
- Required: foundational technical knowledge in quality engineering/assurance/systems and regulatory compliance.
- Strong communication, teamwork, and problem-solving skills.
- Understanding of project-management principles.
- Ability to prioritize customer and patient needs.
- Above-average digital literacy and proficiency with common business applications (e.g., Microsoft Office).
Nice To Haves
- Desired: experience in 21 CFR 820, MDD and/or ISO 13485 environments and support for third‑party inspections/audits.
- Desired: awareness of product development, operations, supplier management/procurement, and business risk/impact of compliance issues.
Responsibilities
- Communicate business issues/opportunities upward and ensure personal and company compliance with applicable laws, regulations, and corporate policies.
- Perform other assigned duties as needed.
- Help design, develop, implement, and maintain quality systems in conformance with applicable standards and regulations.
- Support change management and standardization activities to improve quality-system processes and tools.
- Review/approve quality records and support system monitoring and metrics.
- Ensure verification of system effectiveness and feed results into management reviews; coach local Quality functions on management review responsibilities.
- Liaise across the organization to establish and document quality procedures.
- Identify continuous-improvement opportunities (e.g., procedural harmonization) and promote J&J best practices.
- Support global training initiatives and deliver quality-systems education to enable consistent execution.
- Support inspection readiness and act as a subject-matter expert during audits/inspections.
- Collaborate on corrective and preventive actions, ensuring timely and effective completion.
- Maintain awareness of regulatory changes and ensure proactive organizational response.
- Represent Quality on cross-functional teams across the organization.
Benefits
- 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.
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
