Johnson & Johnson · 1 day ago
Sr Manufacturing Quality Engineer
Danvers, Massachusetts, United States of America
Full-time
Onsite
Mid, Senior Level
$79K/yr - $128K/yr
2+ years expJohnson & Johnson is a leader in healthcare innovation, dedicated to developing personalized treatments. They are seeking a Sr. Manufacturing Quality Engineer to provide quality engineering support for the development and manufacturing of life-saving medical devices while ensuring compliance with quality system regulations.
Hospital & Health Care
Responsibilities
Provide quality engineering support in the development and manufacturing of new and existing equipment and facilities
Ensure compliance of manufacturing processes and areas to all applicable quality system regulations
Lead Quality reporting such as, key performance metrics, goals, and objectives for capital products
Lead and support activities related to the Material Review Board for facilities
Lead non-conformance investigations, including cause analysis, documenting findings, and approving material dispositions. Promptly address any quality concerns through corrections, corrective/preventative actions, and Escalations for any facility and environmental non conformances
Monitor and analyze production information to support risk management and provide direction for corrective and preventive actions (CAPA) and/or process improvement activities for facilities
Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), Test method validations (TMV) for facility expansion
Collaborate with manufacturing engineering to ensure the implementation of necessary process controls and validations, while adhering to established guidelines (GMP)
Support process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products. Identify key process input variables and key process output variables
Support Quality Management System (process development, creating and editing new and existing SOPs). Support internal and external auditing requirements in manufacturing for capital products
Qualification
Required
A Bachelor's degree in a relevant Engineering field is required
2-4 years of experience in Quality Assurance/Quality Engineering (QA/QE) in the medical device field
Experience with formal problem-solving methodologies and deductive skills
Good understanding of FDA QSRs, ISO13485, ISO14971
Experience with handling non-conforming material and assemblies, including root cause investigations
Experienced in qualification of production equipment and validation of production processes
Preferred
Experience with facility moves and implementation of new equipment in facilities
Blackbelt or lean certified
Benefits
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
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
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
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