Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.
Our Quality Engineer applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments. This role is responsible for planning and conducting projects and assignments with technical responsibility or strategic input. They will receive intermittent, moderately detailed instructions from technical Quality leaders at different levels, in addition to other stakeholders.
Key Responsibilities:
- Utilize quality engineering principles and problem-solving skills to develop and optimize products/processes.
- Utilize statistical tools and techniques to establish sampling plans.
- Develop and implement control plans consistent with product classification.
- Lead the process monitoring and control methods consistent with the level of process/product risk, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc..
- Ensure that Test Methods and Quality procedures are executed in compliance with specifications and standards.
- Work in development, writing, updating and review of test methods, SOPs, protocols and specifications as needed.
- Provide guidance to project teams and business partners to ensure compliance with company policies and procedures as well as medical device regulations.
- Monitor quality data and metrics on a regular basis to that ensure appropriate investigation, correction action, and/or escalation is conducted as required for recurring trends.
- Analyze process-, product-, test-, Lab- and Quality Management System data and investigates for improvement opportunities.
- Communicate business-related issues or opportunities to next management level.
- Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Qualifications
- Minimum Bachelor’s or equivalent degree in Engineering or Science required
- Minimum 2 years of relevant work experience required
- Requires Quality experience; medical device or other highly regulated industry preferred
- Knowledge of product/process Risk Management (DFMEA/PFMEA or Gage R&R Analysis, FDA and ISO standards) and GMP preferred
- Experience with Quality and Statistical tools/software (e.g., Minitab) preferred
- Technical training or experience preferred with Lean and Six Sigma Methodologies, Measurement System Analysis, or DOEs
- Understanding of the NPI (New Product Introduction) process and Process Validation preferred
- Ability to identify and simplify complex issues, as well as demonstrated ability for proactive, organized, and systemic approach to making decisions and resolving issues
- Ability to work in a team and demonstrate good interpersonal, organization, and oral/written communication skills
- Requires English fluency (speak/read/write); Spanish fluency is helpful
- Requires up to 10% travel, domestic and international
Are you interested in joining a diverse team that is helping improve patient care and drive innovation from San Lorenzo, Puerto Rico? Apply today!
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
United States-Puerto Rico-San Lorenzo-Carr 183 Km 8.3 Area Ind Hato PO Box 982
Organization
Ethicon Endo Surgery, LLC (7597)
Job Function
Engineering
Requisition ID
1536200828
Source: Indeed.com
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