Johnson & Johnson MedTech · 2 days ago
Quality Systems Engineer
Raynham, MA
Full-time
Onsite
Entry, Mid Level
$65K/yr - $105K/yr
2+ years expJohnson & Johnson MedTech is dedicated to healthcare innovation, striving to improve health outcomes globally. The Quality Systems Engineer will support and enhance the quality management system, develop quality metrics, and provide training to ensure compliance across MedTech entities.
Hospital & Health Care
Responsibilities
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
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
Qualification
Required
Bachelor's degree in engineering, a scientific discipline, or related technical/quality field (or equivalent)
Minimum of 2 years relevant work experience
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)
Preferred
Experience in 21 CFR 820, MDD and/or ISO 13485 environments and support for third‑party inspections/audits
Awareness of product development, operations, supplier management/procurement, and business risk/impact of compliance issues
Analytical Reasoning
Business Alignment
Business Behavior
Collaborating
Communication
Compliance Management
Data Compilation
Data Quality
Data Savvy
Document Management
Execution Focus
Quality Auditing
Quality Control (QC)
Quality Management Systems (QMS)
Quality Services
Quality Standards
Systems Analysis
Training People
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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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