Johnson & Johnson MedTech · 8 hours ago
Staff Quality Engineer
Palm Beach Gardens, FL
Full-time
Onsite
Senior Level, Lead/Staff
$94K/yr - $152K/yr
6+ years expJohnson & Johnson is a leader in healthcare innovation, committed to improving health for humanity. They are seeking a Staff Quality Engineer to provide overall quality assurance leadership in manufacturing areas, ensuring compliance with good manufacturing practices and supporting New Product Introduction and Value Improvement projects.
Hospital & Health Care
Responsibilities
Develops standard operating procedures, specifications, and provides technical transfer and validation support
Minimizes sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation
Audits and approves manufacturing, quality, engineering and validation documents for conformance to business practices and departmental procedures
Provides data and documentation in support of the development of validation strategies. Acts as liaison to the regulatory affairs department to perform initial regulatory review of all engineering changes and modifications to products
Provides sampling plans and approves inspection methods for evaluation and testing of components and products
Provides support and expertise in reliability planning and reliability growth demonstration during new product development
Qualification
Required
University/Bachelor's or equivalent degree in Engineering, Life Science, or related field is required
A minimum of six (6+) years of related work experience
Experience working in regulated industries
Professional quality or Manufacturing Engineering experience
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
Strong communication, teamwork, problem solving and decision-making skills
Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc
Ability to perform 'hands on' troubleshooting and problem solving
Strong mentoring, coaching and leadership skills
Demonstrated project management and project leadership abilities
Experience in process quality and validation
Preferred
Strong knowledge of statistical software packages with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making
Understanding of the NPI (New Product Introduction) process
Benefits
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)).
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.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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