Johnson & Johnson

Sr Manufacturing Quality Engineer

Danvers, Massachusetts, United States of America · Senior

Sponsorship not specified$79k-$128kDetected 5 hours ago

Data AnalysisAuditingSupply ChainProcess ImprovementGMPFDA RegulatoryMedical DevicesProblem SolvingMentoring

About the role

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.
Your unique talents will help patients on their journey to wellness.

Provide quality engineering support in the development and manufacturing of new and existing equipment and facilities
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.
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

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
Experience with facility moves and implementation of new equipment in facilities
Blackbelt or lean certified
Up to 10% domestic and international travel is required
Role is on site at our Danvers, MA facility
Johnson & Johnson is an Equal Opportunity Employer.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs.
Internal employees contact AskGS to be directed to your accommodation resource.

https://www.careers.jnj.com/employee-benefits
Vacation -120 hours per calendar year
Holiday pay, including Floating Holidays -13 days 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
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.

If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers.

This listing is sourced directly from Johnson & Johnson's careers page and normalized into a canonical job model.