AddressDescription
Ethicon LLC, part of Johnson & Johnson Family of Companies, is recruiting for a(n) Quality Laboratory Leader, located in San Lorenzo, PR.
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.
Under the direction of the Site Quality Lead and with the objective of maintaining high quality standards, ensure products are manufacture in compliance with regulatory requirements. Provides leadership, technical support and direction to Operations and Quality Assurance Team during the design, development, improvement, revision and implementation of quality systems for efficient manufacturing processes. Is the deputy Management representative, coordinates Quality Assurance support to all Site functions and directly supervises Quality Laboratory Supervisors, Sterilization SMEs, Quality Engineers, Quality Team Leaders, Quality Systems Team Leaders/Analyst and/or non-exempts associates in day to day activities supporting manufacturing lines, operator certification program, incoming and finished goods inspections, laboratory and CME environmental monitoring, all in accordance with applicable regulations and Ethicon written specification ad quality standards. Provide support and expertise on problem solving, process improvements and in the usage of quality tools.
Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!
Key Responsibilities:
- Coordinates the deployment and utilization of resources for tactical day to day work. This includes but not limited to working with Operations, Materials Management and Quality Assurance to facilitate testing and release scheduling.
- Administers the testing and controlling of raw material, finished product quality and in process quality, assuring compliance with company standards and applicable regulations.
- Responsible for the evaluation and disposition of WIP and questionable raw materials.
- Advice Business Units on inspection and testing procedures, provide direction and recommendations when required.
- Initiates and maintains interplant communications of quality issues.
- Maintains close interaction and network with peers at other Plants to address quality related issues.
- Coordinates available resources to achieve a reliable, efficient, and productive operation.
- Facilitates QA support to new product launches to assure a successful implementation.
- Cultivate collaboration and supports total associate involvement.
- Assists in the preparation of the Annual Department Budget.
- Supervises Good Housekeeping practices, good manufacturing practices and employee safety.
- Ensures that direct reports, 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.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Qualifications
Education:
- Bachelor’s Degree in Science, or other technical field is required.
Experience and Skills:
Required:
- Minimum of six (6) years of related experience in a regulated environment
- Minimum of three (3) years of people management experience.
- Work experience in Quality Laboratory
- Knowledge of manufacturing principles and practices, and procedures.
- Ability to communicate effectively with a diverse clientele base.
- Sophisticated digital literacy and use of software application(s).
- Fully Bilingual (Spanish & English).
- Strong technical writing skills.
- Strong Project management skills.
Preferred:
- Experience in the Medical Device industry or medical field.
- ASQ Certified Quality Auditor (CQA) or ISO Certified Lead Auditor.
Other:
- Able to enter data on spread sheet and database applications is preferred.
- Ability to work collaboratively with coworkers.
- 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.careers.jnj.com.
