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Quality Systems Manager - 2406202507W

Description

Job Title: Quality Systems Manager

Department: Quality

Reports To: Quality Director

Closing Date : 5th August 2024

Vision Care Ireland, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Systems Manager.

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/ .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver significant solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we cultivate a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Job Summary:

This role develops, implements, and improves the site quality system in harmony with Franchise, Medical Device (MD), Enterprise and in accordance with applicable standards and regulations.

Duties & responsibilities

– Ensures that the Site’s Quality System (including but not limited to change management, NC and CAPA, Management Review processes) is established and maintained in harmony with Franchise, MD&D, Enterprise Quality Systems and in accordance with applicable standards and regulations, and report on the performance of the Quality System to the Organization and Franchise Management.

– Monitors quality system trends and brings those in need of corrective action to upper management's attention and assures implementation of corrective action as required and maintains documentation accordingly.

– Assures compliance to procedures and regulations by requesting and supervising corrective actions as vital.

– In partnership with the wider organization proactively reviews the system problems and procedures and identifies solutions to problems and opportunities for improvement.

– Suggests and debates alternative methods and procedures in solving Quality System problems and meeting changing business opportunities.

– Collaborate with other management personnel in formulating and establishing local and worldwide company policies, and procedures, and goals.

– Develops initial and subsequent modifications of quality system program to delineate areas of responsibility, personnel requirements, and operational procedures within program.

– Reviews' industry publications, articles, and abstracts to stay abreast of developments in industry.

– Estimates budgets and maintains operating costs within constraints of those budgets.

– Leads subordinates. Is responsible for the overall direction, coordination, and evaluation of the department.

– Carries out management responsibilities in accordance with the organization's policies and applicable laws.

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

– Responsibilities include interviewing, hiring, and training employees; planning, assigning, and advising work; appraising performance; rewarding and focusing employees; addressing complaints and resolving problems.

– Responsible for compliance in accordance with regulations and standards such as and from, but not limited to 21 CFR 820; 21 CFR 210/211; ISO 13485; EU MDD/MDR; Australian Therapeutic Goods Regulations No. 236; Brazil GMP Regulations Resolution RDC n°16; CMDR – SOR98-282; Japan MHLW Ordinance No. 169

Qualifications

Experience & education

– Minimum of a Bachelors degree in a related science/engineering/business field.

– 6 years dynamic experience working in a regulated industry with a minimum of 3 years in a medical device or pharmaceutical or equivalent manufacturing environment.

– Minimum of 3 years managerial/supervisory experience required or combined with completion of sophisticated management training/courses.

Desirable:

– Masters' qualification.

– 3 years experience working in quality leadership roles.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES

– Detailed knowledge of FDA and International Regulatory requirements.

– Excellent organizational, interpersonal, written and oral communication skills required.

– In-depth solid understanding of quality and operations systems and processes.

– Proven excellence in presentation and meeting facilitation skills.

– Shown success in the execution and application of quality systems, including the application of statistical principles, theories, and concepts.

– Solid understanding of analytical software (e.g. SPC/Minitab, etc.).

– Shown leadership and problem solving skills.

– Ability to work on own initiative.

– Flexible work ethic.

– Innovative development techniques and critical thinking abilities.

– Ability to prioritize and balance multiple tasks, and to facilitate and resolve cross functional activities and issues.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Primary Location Europe/Middle East/Africa-Ireland-Limerick-Limerick

Organization Johnson & Johnson Vision Care (Ireland) Limited (8182)

Job Function Quality Systems

Req ID: 2406202507W