Quality Systems Engineer

Johnson & Johnson Innovative Medicine; Danvers (MA); On-site; USD 79,000 - 128,000; Full time

Benefits offered by this job

Consolidated retirement plan (pension)

401(k) savings plan

Long-term incentive program

Vacation 120 hours/year

Job summary

Johnson & Johnson Innovative Medicine is seeking a Quality System Engineer to develop, implement, and maintain quality management systems ensuring compliance with industry standards and regulatory requirements. The role requires cross-functional collaboration across engineering, manufacturing, and regulatory teams.

You will drive continuous improvement initiatives, participate in audits, manage CAPAs, and provide staff training to reinforce a culture of quality across the organization.

Qualifications

• Bachelor’s degree in engineering or related field.
• Minimum three years' experience with quality systems in regulated industry.
• Knowledge of ISO, FDA, or other applicable standards.
• CQE or Six Sigma certification preferred.

Responsibilities

• Design and oversee quality control processes and documentation.
• Monitor system performance and track quality metrics.
• Conduct internal and external audits and support CAPA implementation.
• Provide training on quality system protocols.
• Collaborate with engineering, manufacturing, and regulatory teams.
• Track CAPAs and Non-Conformances with regulatory documentation.

Skills

Quality systems

Regulatory standards

Six Sigma CQE

Analytical skills

Communication

Education

Bachelor's degree in engineering

Quality Management

Job description

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

• 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.

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