The Quality Engineer Senior plans, conducts and directs engineering projects or studies including complete projects that require advanced knowledge in specialized field.
He/she applies a wide and diverse knowledge of the engineering principles and practices within the assigned areas.
He/she can coordinate and direct personnel activities of technical support and is responsible of the technical development of the personnel assigned.The Quality Engineer Senior will use quality engineering tools and practices for the effective and efficient development of transfers and the maintenance of products / processes in the complete life cycle of the product.
The position holder will also use quality engineering principles and investigation skills and problem resolution to improve and maintain the products / processes that are aligned with quality and the business global vision.
He/she will the appropriate risk management to prevent unforeseen failure modes and improvethe capacity of the processes.
This person will support the business processes.If CSS Position:This position willhave responsibilities across ETHICON and Cardiovascular and Specialty Solution (CSS) Companies Johnson and Johnson Family of Companies) including a span of multipleproductplatforms such as General Surgical Devices, Sutures, ENT, Infection Prevention, Electrophysiology and Surgical and Non-SurgicalAesthetics
DUTIES & RESPONSIBILITIESUnder limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:Business Improvement Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.
Performs benchmarking to develop more effective methods to improve quality.
Support the development of quality engineering andcompliance of the quality with the adequate abilities for the introduction of new products, and management of the life cycle of the product.
Revises and approves engineering change orders.
(ECOs).Compliance / Regulatory Revises / analyzes if the currentproducts and processes (including taken actions or decisions) comply with the regulations, such as QSRs, ISO 13485, etc.
including providing support during internal and external audits.
Participates in the preparations activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.).
Responds to internal or external audit observations related to the quality engineering function.
Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems.
Performs periodical audits to the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS.
Checks the audit results of the area to ensure that the corrective and preventive actions are adequate.
**Qualifications**:
Bachelor in Engineering: Mechanical, Electrical, Industrial or applicable science.
4 to 6 years of work experience, or demonstrated performance.REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES: Use of computer packages.
Ability to communicate in English, orally and written.
Knowledge of product / process Risk Management (FDA and ISO regulations), preferably.
Advanced technical training and experience in the use of Statistics and Lean methodologiesand Six Sigma, including Measuring System Analysis, SPC, DOEs, reliability, etc.
Strong knowledge of statistical software packages, preferably, with the capacity of pre-visualizing, create graphs and analyze data and be capable of presenting data that facilitates the taking of decisions.
Ability to perform an "active involvement" in the solution of problems and resolution of problems, preferably.
Capacity to solve problems and provide good judgment, highly desirable.
Demonstrated management abilities of projects and leadership projects, preferably.
Certifications such as CQA and CQE (preferably), CBA and Green Belt are a plus