Quality Systems Engineer

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 Med Tech, 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

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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

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* Job Description:

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* ** 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, c and promote continuous improvement initiatives throughout the organization.

** Key Responsibilities*
* + Design and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed.

+ Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.

+ Conduct internal and external audits, and support the implementation of corrective and preventive actions to address identified issues.

+ Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team.

+ Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments.

+ Design and oversee quality processes and documentation to ensure accurate and consistent procedures are followed.

+ Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.

+ Participate in internal and external audits, and support the implementation of corrective and preventive actions to address identified issues.

+ Manage and track Corrective and Preventive Actions (CAPA) and Non-Conformances (NC), ensuring timely resolution and documentation in accordance with regulatory requirements.

+ Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team.

+ Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments

** Qualifications*
* + Bachelor's degree in engineering, Quality Management, or a related field.

+ At least three years of experience working with quality systems in a regulated industry.

+ Comprehensive understanding of ISO, FDA, or other applicable standards.

+ Strong analytical, problem-solving, and communication skills.

+ Certification in quality management, such as Six Sigma or CQE, is preferred.

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* Required Skills:

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* ** Preferred

Skills:

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* Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaborating, 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 - $

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…