SITE QUALITY LEAD

MENTOR, a member of Johnson & Johnson's Family of Companies, is recruiting for a Site Quality Lead, to be located in Irving, Texas.
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.
nj.
om/.
The Site Quality Lead is responsible for the overall management and efficiency of the quality management system and provides overall direction to the quality function for Mentor Texas L.
.
The Site Quality Lead plans, implements, and runs 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.
Key Responsibilities.
Serves as the site Management Representative and the legal manufacturer Person Responsible for Regulatory Compliance (PRRC) as defined in the Quality System Regulation, ISO , and EU Medical Device Regulations for the Mentor Irving TX.
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 Quality objectives and annual 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 regulatory needs.
Prioritize goals to achieve deadlines and the objective.
Supervising 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 for analyzing, evaluating and controlling product risk throughout product realization.
Qualifications Education.
A minimum of a Bachelor's degree is required.
Experience and Skills.
Required.
Minimum 10 years related experience in quality and regulatory functions in the Medical Device industry.
Experience in the governance of Quality Systems and Quality Audit programs.
Prior people management experience.
Preferred.
ASQ certified Proficient in project management, crafting credibility within team members and growing 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.
Ability to periodically interact with associates and processes in a special environment such as a clean room.
Ability to wear protective garb such as lab or clean room gowns.
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.
Other.
This position may require up to a 10% of domestic and/or international travel.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.