Staff Quality Systems Engineer

Biopharma Asia; Danvers (MA); On-site; USD 96,000 - 155,000; Full time

Job summary

Johnson & Johnson in Danvers, MA is seeking a Staff Quality Systems Engineer to lead CAPA and Nonconformance in a regulated medical device environment, based in Danvers.

You will drive quality system improvements, ensure global regulatory compliance, mentor junior engineers, and collaborate with cross-functional teams across Manufacturing, R&D, Regulatory Affairs and Supplier Quality. Travel up to 10% may be required.

Qualifications

• Bachelor's degree in engineering, life sciences, or related field; advanced degree preferred.
• 5–7 years of quality engineering in the medical device industry.
• Deep understanding of FDA QSR (21 CFR Part 820), ISO 13485.
• Proven experience managing CAPAs and NCs in a regulated environment.
• Experience with electronic QMS platforms (EtQ, SAP).
• Certified Quality Engineer (CQE) or CMQ/OE preferred.

Responsibilities

• Lead complex investigations of product and process nonconformances using RCA methodologies (FTA, 5 Whys, Fishbone, DOE).
• Oversee end-to-end CAPA and NC process with timely execution and documentation.
• Serve as SME for CAPA/NC during internal audits, FDA inspections, and Notified Body assessments.
• Analyze CAPA/NC trends to identify systemic issues and improvement opportunities.
• Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supplier Quality to resolve issues.
• Support risk management per ISO 14971 including CAPA/NC risk assessments.
• Mentor and train junior quality engineers on CAPA/NC and regulatory requirements.
• Contribute to QMS development and SOP/templates improvement.
• Lead or support global CAPA/NC harmonization initiatives across sites.
• Travel up to 10% for regulatory inspections and internal audits.

Skills

CAPA management

Root-cause analysis

Quality systems

QMS

Six Sigma

Lean

Project management

Leadership

Education

Bachelor's degree in Engineering

Advanced degree preferred

Tools

EtQ

SAP

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:

We are searching for the best talent for a Staff Quality Systems Engineer to lead and optimize CAPA and Nonconformance (NC) processes within a regulated medical device environment. This role will be based in Danvers, MA.

Purpose:

This role is instrumental in driving quality system improvements, ensuring global regulatory compliance, and mentoring junior engineers. The position includes travel to support cross-site initiatives, supplier quality activities, and audit readiness.

You will be responsible for:

• Lead complex investigations of product and process nonconformances using advanced root cause analysis methodologies (e.g., Fault Tree Analysis, 5 Whys, Fishbone, DOE).
• Oversee the end-to-end CAPA and NC process, ensuring timely execution, thorough documentation, and effective implementation of corrective and preventive actions.
• Serve as a subject matter expert (SME) for CAPA and NC processes during internal audits, FDA inspections, and Notified Body assessments.
• Analyze CAPA/NC trends and metrics to identify systemic issues and recommend strategic quality improvements.
• Collaborate with cross-functional teams including Manufacturing, R&D, Regulatory Affairs, and Supplier Quality to resolve quality issues and implement sustainable solutions.
• Support risk management activities in accordance with ISO 14971, including risk assessments related to CAPAs and NCs.
• Mentor and train junior quality engineers and other stakeholders on CAPA/NC processes, regulatory requirements, and quality tools.
• Contribute to the development and continuous improvement of the Quality Management System (QMS), including SOPs, work instructions, and templates.
• Lead or support global harmonization initiatives for CAPA/NC processes across multiple sites or business units.
• Up to 10% travel may be required to support: Regulatory inspections and internal audits at other facilities
• Training and collaboration with global teams

Qualifications/Requirements:

• Bachelor's degree in engineering, Life Sciences, or related field; advanced degree preferred.
• Minimum 5-7 years of experience in quality engineering /quality systems within the medical device industry.
• Deep understanding of FDA QSR (21 CFR Part 820), ISO 13485, and EU MDR.
• Proven experience managing CAPAs and NCs in a regulated environment.
• Strong analytical skills and proficiency in quality tools (e.g., 8D, FMEA, Six Sigma, Lean).
• Experience with electronic QMS platforms (e.g., EtQ,SAP).
• Excellent communication, leadership, and project management skills.
• Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Lean Six Sigma Black Belt or similar preferred.
• Experience with complaint handling, design controls, and post-market surveillance preferred.
• Familiarity with global regulatory requirements (e.g., USFDA, Health Canada, TGA, PMDA) preferred.
• Ability to influence cross-functional teams and drive quality culture preferred.

The anticipated base pay range for this position is :

$96,000.00 - $155,250.00

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)).

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 period 10 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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.