Quality Systems Engineer

Johnson & Johnson • Full-time • US014 MA Raynham - 325 Paramount Dr, United States of America • 2w ago

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.

Duties & Responsibilities:

General / Compliance

Communicate business issues/opportunities upward and ensure personal and company compliance with applicable laws, regulations, and corporate policies.
Perform other assigned duties as needed.

Quality Systems (Core)

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.

Extended / Strategic

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.

Experience and Education

Bachelor’s degree in engineering, a scientific discipline, or related technical/quality field (or equivalent).
Minimum of 2 years relevant work experience.
Desired: experience in 21 CFR 820, MDD and/or ISO 13485 environments and support for third‑party inspections/audits.
Required: foundational technical knowledge in quality engineering/assurance/systems and regulatory compliance.
Desired: awareness of product development, operations, supplier management/procurement, and business risk/impact of compliance issues.

Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations:

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).
No specific certifications/licenses listed (none required in the source).

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Required Skills:

Preferred Skills:

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

The anticipated base pay range for this position is :

$65,000.00 - $104,650.00

Additional Description for Pay Transparency:

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)).

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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

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