Quality Systems Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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

• Bachelors 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 thirdparty 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).

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 :

$65000.00 - $104650.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

For additional general information on Company benefits please go to: - position is eligible to participate in the Companys 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