Johnson & Johnson Careers

Business Unit Quality Manager

Limerick, Ireland
Quality Assurance


Job Description

Requisition ID: 1905753524W

Job Purpose:

You will have quality ownership of the assigned business unit value streams. Have joint leadership for assigned value streams with operations and engineering leads. Accountable for joint goals and business imperatives. Management of performance of assigned staff ensuring the organization’s product and department processes meet world-wide government regulations and company quality standards. Defines and implements the business unit quality program. Maintains the quality program for effectiveness, communicates quality performance, and drives quality improvement initiatives. Evaluates the impact of internal and external quality events. Provides quality consultation to internal and external customers in support of organizational objectives.

Responsibilities:


MAIN AREAS OF RESPONSIBILITY:
− Leads the performance of assigned staff. (This includes leading day-to-day activities, providing training and development, and completing performance evaluations).

− Leads the execution of the organization’s/business unit’s quality management system (This includes Non-conformance, RCI, CAPA, Customer Complaints, etc.)

− Provide quality consultation to internal and external customers in support of organizational objectives.

− Direct cost improvement projects within department and in support of internal customers.

− Track, report, & improve key performance indicators and quality indicators for compliance and efficiency.

− Plans and leads annual spending and headcount budgets.

− Acts as the contact for regulatory groups on scientific issues and audits.

− Performs other related duties as assigned by management.

− Responsible for compliance in accordance with regulations and standards such as and from, but not limited to ISO 13485, EU MD Directive/Regulations, EU MDR Directive/ Regulations, ISO-14971 and Medical Device Single Audit Program (MDSAP).


EDUCATION AND EXPERIENCE REQUIRED FOR ROLE
Essential:

− Minimum of a Bachelors degree in a related science/business discipline

− 10+ years industry experience working in a Quality Assurance regulated medical product environment.

− Minimum of 5 years managerial experience or advanced management training.

− Thorough knowledge of FDA and International Regulatory requirements.

− Excellent organizational, social, written and oral communication skills required.

− In-depth working knowledge of quality and operations systems and processes.

− Demonstrated excellence in presentation and meeting facilitation skills.

− Known to work in the execution and application of quality systems, including the application of statistical principles, theories, and concepts.

− Working knowledge of analytical software (SPC/SAS/Minitab, etc.).


− CONFIRMED LEADERSHIP AND PROBLEM-SOLVING SKILLS
− Ability to work on own initiative

− Flexible work ethic


− INNOVATIVE DEVELOPMENT TECHNIQUES AND STRATEGIC THINKING ABILITIES
− Ability to prioritize and handle multiple tasks, and to facilitate and resolve cross-functional activities and issues.

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.





Qualifications
EDUCATION AND EXPERIENCE REQUIRED FOR ROLE
Essential:

− Minimum of a Bachelors degree in a related science/business discipline

− 10+ years industry experience working in a Quality Assurance regulated medical product environment.

− Minimum of 5 years managerial experience or advanced management training.

− Thorough knowledge of FDA and International Regulatory requirements.

− Excellent organizational, social, written and oral communication skills required.

− In-depth working knowledge of quality and operations systems and processes.

− Demonstrated excellence in presentation and meeting facilitation skills.

− Known to work in the execution and application of quality systems, including the application of statistical principles, theories, and concepts.

− Working knowledge of analytical software (SPC/SAS/Minitab, etc.).


− CONFIRMED LEADERSHIP AND PROBLEM-SOLVING SKILLS
− Ability to work on own initiative

− Flexible work ethic


− INNOVATIVE DEVELOPMENT TECHNIQUES AND STRATEGIC THINKING ABILITIES
− Ability to prioritize and handle multiple tasks, and to facilitate and resolve cross-functional activities and issues.

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.





Primary Location
Ireland-Limerick-Limerick-
Organization
Johnson & Johnson Vision Care (Ireland) Limited (8182)
Job Function
Quality Assurance
Requisition ID
1905753524W