Senior Quality Engineer

Johnson & Johnson

. Develop, modify, apply and maintain quality evaluation and control systems and protocols .

Posted 10/22/2026full-timeDanvers • Massachusetts • United StatesSenior💰 $79,000 - $127,650 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Engineering principles, including IQ, OQ, and PQ validation processes, while ensuring compliance with GMP standards and FDA regulations. Capable of conducting root cause analysis, implementing CAPA action plans, and mentoring teams to uphold product quality and operational excellence.

Highest-signal resume keywords

Quality Engineering ExperienceIQ, OQ, PQ ValidationGMP ComplianceASQ Certified Quality Engineer (CQE)Medical Device Industry Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Evaluation SystemsStatistical AnalysisRoot Cause AnalysisCAPA ImplementationNonconformance ManagementProcess ValidationInspection and Testing ProcessesDocument ControlRisk AssessmentElectrical Systems Knowledge

Soft Skills

Problem-Solving SkillsStrong Communication SkillsTeam LeadershipMentoring AbilitiesProactive Approach

Tools & Technologies

SAPCalibration EquipmentInspection EquipmentStatistical SoftwareDocument Management Systems

Certifications & Qualifications

ASQ Certified Quality Engineer (CQE)ISO 13485 Internal Audit Certificate

Industry Keywords

FDA RegulationsISO 13485EU MDRMedical Device IndustryJohnson & Johnson’s Credo

About the role

Key responsibilities & impact

Develop, modify, apply and maintain quality evaluation and control systems and protocols
Devise and implement methods and procedures for inspecting, testing and evaluating product and production equipment precision and accuracy
Design and analyze inspection and testing processes, mechanisms and equipment
Conduct quality assurance tests and statistical analysis to assess control and manage product quality risks
Undertake root cause analysis of incidents requiring corrective action
Provide Quality Engineering support across manufacturing and quality operations, including production, incoming inspection, nonconformance management, equipment and calibration, and process validation
Document production nonconformity, conduct investigations, assess product risk and recommend disposition with MRB members
Define and implement CAPA action plans and effectiveness monitoring from internal and external audits
Coach team members regarding Quality Engineering nonconformances and corrective and preventive actions
Escalate Quality Engineering issues or concerns to the next management level
Identify, document, investigate and resolve Quality Engineering nonconformances
Support process validations and revalidation for current and new processes, including IQ, OQ and PQ
Support the incoming inspection department as needed
Collaborate with the equipment department on PM and calibration procedural updates and calibration-related nonconformities
Support operations primarily at the Danvers site, with additional support for the Woburn site

Requirements

What you’ll need

Bachelor’s degree in Engineering or a related technical field
2–4 years of relevant Quality Engineering or related experience
Solid understanding of IQ, OQ, PQ validation processes and GMP compliance
Proven track record to work independently and manage multiple tasks effectively
Excellent problem-solving skills and a proactive approach to challenges
Strong communication skills, with the ability to mentor and lead teams effectively
Ability to support both the Danvers and Woburn sites
Working knowledge of SAP (preferred)
ASQ Certified Quality Engineer (CQE) certification (preferred)
Knowledge of electrical systems, schematic drawing and IPC 610 (a plus)
Experience in medical device industry under FDA regulations (21 CFR part 820), ISO 13485 and EU MDR
ISO 13485 Internal audit certificate (a plus)
Understanding and application of Johnson & Johnson’s Credo and Leadership Imperatives
Relocation support is not available

Benefits

Comp & perks

Retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Immigration sponsorship eligibility, if required