Senior/commercial Quality Specialist

Responsible for overall quality and compliance leadership Johnson & Johnson Surgical Vision (JJSV) country Marketing Company (MC) or Local Operating Company (LOC) or commercial entity. This will include all distribution centers, warehouses and third-party logistics operations affiliated with JJ Vision.

Responsible for implementing and managing the Johnson and Johnson Vision country Quality Management System for the Regional and Commercial Quality organization. Position will be responsible for all in-country JJ Surgical Vision Quality & Regulatory compliance including compliance to the Franchise. Position will partner with JJ Vision Franchises Quality, Regional JJSV leadership and the Johnson & Johnson Enterprise quality organization to drive improvements in quality and compliance. Management of programs and projects to ensure the achievement of planned quality objectives. Selects trains and develops key staff to ensure availability of resources to support the QMS objectives. Escalation of significant quality and products issues. Support department budgets and executes against approved plan. Responsible for the management of on-site external agency audits to ensure maintenance of licenses and standards. Position will lead, coordinate and prepare for external audits. Position will partner with Jacksonville and Santa Ana based Product Quality Managers, Regional JJ Vision leadership, MD&D Commercial Quality Organization, Consumer Commercial Quality Organization and Enterprise Regulatory Compliance (ERC) group to drive improvements in quality and compliance.

Proactively monitors, analyzes and improves all aspects of quality compliance, quality control and customer complaint process in-order to drive the Total Customer Experience. Responsible for escalation of relevant issues within country to the Franchise, facilitating the non-conformance and CAPA processes, ensuring compliance with customer complaint process, and all quality assurance components of MC/ LOC and distribution networks. Position will communicate and partner with other Regional Quality personnel in-order to implement a worldwide quality management system for JJV, analyze global trends or early warning signals, and proactively prepare for external audits. Position will be the country VOC for product quality and regulatory and quality compliance. Position will create in-country product quality and compliance KPI’s and implement improvement plans. Position will analyze global trends or early warning signals and proactively prepare for governmental audits. Position will develop and implement in-country quality procedures as necessary.

Finally, this position will adhere to environmental policy and procedures and support department environmental objectives.

**Responsibilities**:

- Provides in-country leadership for implementing and continuously improving quality, Quality Management Systems and compliance (40%)
- Co-lead or represents JJV country to other J&J departments (e.g. ERC), external audiences for audits, registrations, and local regulators and Health Authorities (20%)
- Communicates to all levels of the country organization (15%)
- Authorized Representative at the country Quality Office (15%)
- Performs other related duties as assigned by Management (10%)

**Qualifications**:
**Requirements**:

- A Bachelor Degree is required with 5 years above working experience in technical / quality / regulatory role in the Medical Device Industry preferred
- Ability to travel up to 10% required
- Good project management skills required
- Good communication, interpersonal and organizational skills required.
- Thorough understanding of in-country regulatory / compliance.
- Experienced with direct communications and interactions with end customer/ user.
- Flexible in undertaking tasks and working hours.
- Exhibit leadership potential and self-starter is preferred.
- Ability to lead and drive the changes necessary to support and build the business

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.