Johnson & Johnson Careers
Senior NPI QA ENgineer
Requisition ID: 1905730579W
"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo
Senior NPI Quality Engineer
The Senior NPI Quality Engineer plans, conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. They apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. They may coordinate and direct activities of technical support staff. The Senior NPI Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. He/she will partner with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges for New Product Introduction.
Tasks & Responsibilities:
- Provides support in developing operating procedures, develops specifications, and provides technical transfer and validation support. Approves operating procedures and specifications.
- Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
- Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.
- Demonstrate proficiency in applying various tools and methods (for example, Process Excellence) to identify and realize new product or process introductions as well as process and business improvements.
- Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
- Ensures that Process Quality control plans are in accordance with product risk level and are consistently followed. Implements and/or maintains production and process controls using appropriate techniques (for example process capability measures, statistical process controls, process performance metrics).
- Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
- A minimum bachelor’s degree in Engineering or related technical discipline with a minimum of 5 years of experience in quality is required. A Master’s or other advanced degree is a plus.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Experience working in both an FDA and European regulatory environment is preferred. Working knowledge of GMPs, QSR, 21 CFR 820, MDD, ISO13485 and ISO14971 is required. MDR is a plus.
Interpersonal skills / characteristics:
- Ability to “think out of the box”, flexibility, open-minded, team spirit and “can do” attitude are required personal skills. Good technical understanding of manufacturing equipment and processes is required.
- Proven evidences of multi-tasking and proven evidences of taking ownership of action outside of its direct field of responsibilities are required.
- Excellent problem solving, decision-making, and root cause analysis skills are required.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
Minimum Language required
- Fluency in English is required.
- Fluency in French is required.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Medos International Sarl (7898)