Quality Systems Engineer
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At a glance
Requirements
Credentials this posting asks for.
Job overview
J&J Family of Companies is hiring a Quality Systems Engineer. The Quality System Engineer will develop, implement, and maintain quality management systems to ensure compliance with industry standards and regulatory requirements, collaborating with cross‑functional teams to identify improvement opportunities and promote continuous improvement initiatives throughout the organization.
Key focus areas include Design and oversee quality control processes and documentation., Monitor and report on system performance and quality metrics., and Conduct internal and external audits and support corrective actions..
Successful candidates bring Bachelor's Degree In Engineering, 3+ Years Experience With Quality Systems, and Understanding Of ISO FDA Standards. Important skills include ISO Standards and FDA Regulations. Preferred (not required): Analytical Reasoning, Business Alignment, Business Behavior, and Coaching.
Skills & qualifications
Skills
Qualifications
Benefits
Full job description
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
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Design and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed.
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Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.
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Conduct internal and external audits, and support the implementation of corrective and preventive actions to address identified issues.
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Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team.
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Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments.
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Design and oversee quality processes and documentation to ensure accurate and consistent procedures are followed.
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Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.
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Participate in internal and external audits, and support the implementation of corrective and preventive actions to address identified issues.
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Manage and track Corrective and Preventive Actions (CAPA) and Non-Conformances (NC), ensuring timely resolution and documentation in accordance with regulatory requirements.
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Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team.
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Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments
Qualifications
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Bachelor’s degree in engineering, Quality Management, or a related field.
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At least three years of experience working with quality systems in a regulated industry.
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Comprehensive understanding of ISO, FDA, or other applicable standards.
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Strong analytical, problem-solving, and communication skills.
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Certification in quality management, such as Six Sigma or CQE, is preferred.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaboration, 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:
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.
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: - https://www.careers.jnj.com/employee-benefits
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