At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

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About MedTech

Motivated by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your outstanding talents will help patients on their journey to wellness. Learn more at https: //www.jnj.com/medtech

Job summary

• The Quality Engineer will provide QA/QC technical and compliance expertise as part of teams tasked with establishing and assuring system and product quality objectives.

• The Quality Engineer will assure compliance to applicable regulations and J& J Quality Standards and perform quality activities such as data analysis, QMS audits, procedure development, product release, documentation review and implementation of changes to controlled documents.

DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Provides QA technical and compliance support for products and manufacturing related to suppliers, corrective and preventive actions, product/process improvements and training.

• Monitors compliance to Neuravi/Johnson & Johnson policies, procedures, and applicable regulatory requirements, identifying and implementing process and system improvements as applicable.

• Applies detailed, systematic problem-solving methodologies in identifying, prioritizing, presenting, and resolving quality issues.

• Plans, implements, reports and follows-up on quality system audits (supplier and internal)

• Actively participates in and supports departmental activities and responsibilities in accordance with existing procedures and external regulations.

• Makes decisions that are aligned with management objectives regarding work processes, plans and schedules to achieve quality objectives.

• Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.

• Resolves project issues by working with team members, management, suppliers, and others as appropriate.

• Assists department and project leaders in developing and reporting appropriate performance and quality metrics.

• Reviews and approves manufacturing, test and validation data/records to establish conformance to technical specifications and performance standards for existing, new or modified products and processes.

• Provides technical quality mentorship to team members, technician, and inspection staff.

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

EXPERIENCE AND EDUCATION

• Bachelor's Degree in Engineering, Science or related technical field preferred.

• 2 years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite. Auditor certification from an industry recognized organization is beneficial.

• Experience in the preparation for notified body and FDA inspections advantageous.

• Experience in the QA activities associated with a manufacturing environment including project management skills and leadership ability.

• Proficient in basic IT skills relevant to the applications related to the tasks assigned, i.e. the use of word processors and similar windows-based applications, e.g. MS Office products.

• Proven abilities on achieving results within assigned deadlines with an ability to prioritize multiple tasks and operate in a fast-paced environment.

• Experience in less invasive medical device technologies and/or implants preferable.

• Ability to work collaboratively with coworkers and the public.

• Ability to perform duties in accordance with policies and procedures and in to comply civil rights requirements.

REQUIRED KNOWLEDGE,

• Demonstrates an ability to apply, recommend and/or build quality tools and apply them optimally to a variety of business situations related to production, project and team environments.

• Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485: 2016, the European Medical Device Directive/Regulation. Knowledge of other applicable medical device regulations, e.g., Brazilian, Canadian, Australian, Japanese, Korean, etc., advantageous.

• Excellent interpersonal skills and ability to work with people to achieve results.

• Excellent written and communication skills, proficiency in English.

• Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both Neuravi and their customers.

• Motivated and enthusiastic self-starter with the ability to work under own initiative and as a standout colleague.