SITE QUALITY LEAD

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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.
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Job Summary.
The Site Quality Lead will lead the overall management and effectiveness of the quality management system and provides overall direction to the quality function.
The Site Quality Lead will plan, execute and manage the quality management system and activities including quality engineering, quality operations and laboratories, product release, quality systems, corrective and preventive action, non-conforming system, risk management processes, document control and training systems, ensuring compliance with regulatory and company requirements.
The Site Quality Lead serves as Management Representative for the plant and European Authorized Representative (EAR) for the Mentor Legal Manufacturer located outside the EU who places a medical device on the European markets.
The Site Quality Lead has the necessary independence, authority and responsibility to maintain the plant in compliance with all applicable regulatory requirements.
He/she reviews and acts as approval authority or delegated authority, retaining responsibility for all specifications, protocols, validations, fact books, and non-conformances.
Main duties and responsibilities.
Serves as the site Management Representative as defined in the Quality System Regulation and ISO .
Performs the duties of Management Representative as defined in the appropriate Quality Manual and governing procedures.
Serves as the Authorized Representative Person Responsible for Regulatory Compliance (AR PRRC) according to EU-MDR.
Monitoring the quality management system as part of the Quality System Management Review and Quality Audit Program to ensure compliance all applicable regulations and standards.
Reviewing performance of the process/system for the site at planned intervals to ensure suitability, adequacy, and effectiveness of the quality management system and to identify opportunities for improvement.
Ensuring continuous process and product improvement.
Ensuring the promotion of awareness of regulatory requirements throughout the organization.
Communicating to the organization the importance of meeting customer, statutory, and regulatory requirements.
Defining the purpose and objectives of the quality system in the form of the quality policy and annual quality strategic plans, which are further developed into strategic goals and objectives.
Has authority and responsibility to assure the goals supporting the objectives are attained including ensuring the availability of adequate resources in consideration of the yearly manufacture volumes and other needs for the quality system.
Prioritize goals to achieve deadlines and the objective.
Monitoring key quality performance measures and corrective action results.
Responsible for the CAPA system and reporting on the results to management with executive responsibility; recommending and initiating corrective and/or preventive action as appropriate.
Overall risk management planning, including ongoing review of the effectiveness of risk management activities ensuring that policies, procedures and practices are established and documented for analyzing, evaluating and controlling product risk throughout product realization.
Ensures the analysis, evaluation, and presentation of information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends, and design and development of new products.
Oversees the development of policies and procedures related to quality which affect operational and compliance status.
Assures compliance with all local government regulatory requirements and requirements related to things such as sampling plans, design control, and quality systems.
Develops initial and subsequent modifications of product assurance programs to delineate areas of responsibility, personnel requirements, and operational procedures within program.
Evaluates contents of reports on product assurance from department heads and confers with top management personnel in preparation to formulating a fiscal budget.
Oversees and ensures proper execution and compliance in complaint handling investigations performed by the site.
Oversees the quality review resulting from statistical and data analyses for projects involving the design, development or validation of new or existing products and processes.
Ensures troubleshooting and solutions to quality issues through statistical analysis and process excellence tools.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to.
Data Integrity (DI), Good Manufacturing Practices (GMPs), and Good Documentation Practices (GDPs).
Co-approve the Declaration of Conformity, and the Change Notice to the Notified Body.
Ensure that incidents and Field Safety Corrective Actions involving Mentor breast implants are notified to the relevant National Competent Authority when reporting criteria are met according to the current regulation/guidelines.
In consideration of the yearly manufacture volumes and other needs for the quality system, prioritize goals to achieve deadlines and company objectives.
Organizes, plans, leads and manages quality related projects in alignment with company goals.
Prioritizes use of staff resources based on global project team input.
Forecasts headcount and resource needs based on these priorities.
Estimates and oversees staff as part of overall quality budget responsibility.
Develops the strategy, with tactical and operational plans for the quality function and ensures that tactical objectives are met in support of strategic targets.
Recruit, select and develop adequate human resources.
Facilitates the development and training of immediate staff.
Establishes and maintains global relationships with partnering organizations and regulatory bodies.
Leads cross functional teams and provides subject matter expertise to other departments.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
Qualifications Experience and education.
Minimum 10 years related experience in quality and regulatory functions.
University/bachelor’s degree or equivalent.
A combination of experience and education may be considered.
Experience in the Medical Device industry or regulated medical field is required.
Prior management experience is required.
Six Sigma Green Belt or Black Belt is recommended.
Based on education and/or experience, be able to provide appropriate technical input and review of product realization activities including but not limited to design control, validation, and production process controls, product release, and material controls.
Ability to perform duties in accordance with policies and procedures and in to comply civil rights requirements.
Minimum criteria for AR PRRC qualifications are:- A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; or 4 years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Required knowledge and skills Advanced computer skills and use of software applications (MS Office, MS Project Management, PowerPoint, Word, Excel, Outlook etc.) Proficient in project management, creating credibility within team members and expanding capabilities of the group.
Strong Organizational, interpersonal, oral and written communication, presentation skills.
Ability to prioritize multiple commitments and support technical problem-solving duties.
Ability to shift priorities according to changes in company/department needs and open to different ideas/approaches.
ASQ membership, CQE or CQA certification is preferred.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.