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Quality Engineering Supervisor - 2406215042W

Description

Ethicon, a member of the Johnson & Johnson Family of Companies, is recruiting for Quality Engineering Supervisor located in Manati, 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/.

Reports to Quality Operations Lead, Quality Operations Leader or designee and with the objective of maintaining high quality standards for the manufacturing process of Finished Goods products and the compliance with regulatory requirements. Supervises day-to-day activities of the Quality Assurance Technicians, Finished Goods Quality Assurance Technicians, Raw Material Quality Technicians and/or Quality Assurance Laboratory Technicians, in accordance with QSR and Ethicon written specifications and quality standards. Generates quality indicators and supports nonconformance investigation and corrective action implementation at the business unit level and/or Site level. Also, provides technical support and direction to Plant Operations and Quality Assurance during the design, development, enhancement, revision, and implementation of the quality systems for the efficient manufacturing of products and processes. Provide support and expertise on problem solving, process improvements and in the usage of quality tools. Ensure compliance with company policies and procedures such as Design Control, Process Validation, Test Method Validation, and Sampling Plan Development and Review. Generates quality indicators and supports nonconformance investigation and corrective action implementation at the business unit level and/or Plant level.

Responsibilities:

• Supports Internal Compliance Function as required (QSR/ISO training, internal and external audits, trends analysis, etc.).

• Responsible for the evaluation and disposition of WIP and questionable raw materials by inspecting and testing as needed.

• Supports Operations in the generation of quality indicators, evaluation, and implementation of action plans to eliminate root causes of non-conformances and in the development and execution of strategic and tactical plans.

• Lead and/or support Plant Initiatives and/or special projects.

• Supports/initiates investigations of non-conformances (such as but not limited to Nonconformance Reports (i.e NR), CAPA, Audit Observations), and initiates and maintains interplant communications of quality issues.

• Responsible for the coordination, maintenance, and implementation of the Device Master Record.

• Applies Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Root Cause Analysis, Statistical Analysis and Design of Experiments (DOE) to the improvement of products or processes and in solving process/product-related problems. Promotes and applies Process Excellence Methodology to improve products/processes/systems. Supports validations as required.

• Monitor the performance of the CME (Controlled Manufacturing Environment), including but not limited to Product Bioburden monitoring.

• Schedules, assigns, review, and supervise the work of direct personnel.

• Applies Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Root Cause Analysis, Statistical Analysis and Design of Experiments (DOE) to the improvement of products or processes and in solving process/product-related problems. Promotes and applies Process Excellence Methodology to improve products/processes/systems. Supports validations as required.

• Directly supervises QA Technicians and other Quality Assurance Non-Exempts Associates such as Quality Assurance, RMQA, Laboratory, and/or Finished Goods Technicians as required. Provide training, develops and evaluates direct reports.

• Develop, write, and approve procedures, test methods and/or specifications as required.

• Provide expertise in the design, development, and implementation of suitable quality systems for new or existing products & processes.

• Facilitate the design transfer process between corporate and plant environments.

• Approve and support the control and disposition of non-conformance material as per applicable procedures.

• Perform product impact assessments and the determination of non-conformances scope (i.e. bounding).

• 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.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Qualifications

• Bachelors’ Degree in Science, Engineering or related technical field is required.

• A minimum of 4 years of related work experience will be required.

• Experience working in a supervisory role is preferred.

• Experience in a regulated manufacturing industry required.

• Availability to work various schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays is required.

• Intermediate or higher computer skills and use of software application(s).

• Fully Bilingual (Spanish & English) is required.

• EIT, PE License preferred.

• Knowledge of QSR and ISO Standards is required.

• 10% Travel requirement between Ethicon Locations, 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.

Primary Location NA-US-Puerto Rico-Manatí

Other Locations NA-US-Puerto Rico-San Lorenzo

Organization Ethicon Endo Surgery, LLC (7597)

Travel Yes, 10 % of the Time

Job Function Quality Assurance

Req ID: 2406215042W