Johnson & Johnson MedTech · 18 hours ago
Quality Engineer
Johnson & Johnson is a leader in healthcare innovation, dedicated to improving medical care worldwide. They are seeking a Quality Engineer to provide quality assurance leadership in manufacturing areas, ensuring compliance with good manufacturing practices and supporting new product introduction projects.
Hospital & Health Care
Responsibilities
Provides comprehensive quality support for daily manufacturing activity
Manages the initiation, containment, investigation, disposition and closure of Non-Conformances in the PBG and WPB MAKE Sites
Performs and/or supports CAPA records, including risk assessment, root cause investigation, corrective and preventive actions and effectiveness monitoring
Utilizes industry and process excellence standards on a moderately complex level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO)
Addresses or escalates product and process complaints
Evaluates contract manufacturer performance metrics and supports management reviews
Conducts audits of all quality system categories to assess compliance to process excellence standards
Implements comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, demonstrating continuous improvement to man
Facilitates technical issues for manufacturing processes that are to be transferred to satellite facilities
Qualification
Required
University/Bachelor's or equivalent degree in Engineering, Life Science, or related field is required
A minimum of two (2+) years of related work experience
Experience working in regulated industries
This position will require relevant experience working in manufacturing/operations
In-depth knowledge of product/process Risk Management (MDSAP, MDD, MDR, FDA and ISO standards)
Experience and a proven track record of implementing appropriate risk mitigation
Preferred
Advanced knowledge of Six Sigma methodologies
Understanding of the NPI (New Product Introduction) process
Benefits
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
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 MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.