Quality Systems Engineer
About this opportunity
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, 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.
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
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 909 comparable Quality roles across 103 biopharma companies.
Salary context
182 of 909 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 909 comparable roles
+ 42 more countries
Seniority mix
428 of 909 peers have a known seniority level
Therapeutic area mix
1 of 909 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.