Staff Quality Engineer
About The Position
Johnson & Johnson is recruiting for a Staff Quality Engineer, located in Palm Beach Gardens, FL. The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. Our rapidly growing Velys Enabling Tech Operation is in need of a Staff Quality Engineer who provides overall quality assurance leadership of on-site manufacturing areas. Ensures manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards. This position is focused on the support of New Product Introduction and Value Improvement projects implementation to the PBG Site.
Requirements
- 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.
Nice To Haves
- 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
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.
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.
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- 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
- For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
