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COMPANY
Ethicon, Wound Closure and Repair is a trusted, world-wide leader in medical devices company who commits to the advance surgery and improves lives every single day. We are qualified as one of the top best place to work. Joining Ethicon is more than joining a great company, it means belonging to a legacy of innovation, development and philanthropy. For more information, visit www.ethicon.com
JOB SUMMARY*
- The position of Product Release Technician is responsible for quality assurance inspection activities while ensuring compliance to policies, procedures, GDP (Good Documentation Practices), and ISO (International Organization for Standardization) requirements for documentation for PRODUCT RELEASE and the appropriate distribution thereof.
DUTIES & RESPONSIBILITIES*
- Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Know and follow EES policies and procedures related to work activities performed in area of responsibility
- Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies and procedures, for new assignments and for implementation of new policies and procedures. Complete required periodic re-training in areas such as Safety and Environmental.
- Follow all company safety policies and other safety precautions within work area.
- Promote safety to all associates that enter work area.
- Performs routine tests and analyses to assure that products comply with established specifications.
- Post training, for product codes can pull all necessary drawings/material specifications/finished goods specification from appropriate PLM system(s) in order to have up-to-date documents
- Completes record of inspection results, acceptance, rejection and disposition for entry into log books, batch audit records, and/or computer databases.
- Work with NPD and Lifecycle Engineering to assure the application of non-standard test techniques when normal procedures do not fulfill testing needs, as needed.
- Observes discussions with Quality, Engineering, and other relevant departments to learn about corrective actions for reoccurring problems.
- Prioritize and schedule activities (DHR review) for PRODUCT RELEASE (CoC approval) for those product codes appropriately trained to.
- Assist all levels of associates with training and guidance on documentation issues.
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed.
Qualifications
QUALIFICATIONS AND REQUIREMENTS
- High School/ Secondary Education or Equivalent
- 0-2 years’ experience in a highly regulated, quality-centric environment, preferably in a Quality Assurance (QA)/ Quality Control (QC) environment or equivalentperform the position responsibilities.
- Advanced English level is preferred,
- A combination of experience and education can be allowed; see Procedure 100612422.
- Experience in the Medical Device industry or medical field is preferred
- Demonstrated knowledge of manufacturing principles and practices, and procedures
- Experience with : JDEOne, SAP S4 HANA, EtQ
- Internal candidates experience with internal applications: Symfony, CURVE, OneASL
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS *
- Knowledge of Quality Systems for corrective action, product segregation, nonconformity material control and process improvement.
- Ability to use good verbal and written communication skills (technical and nontechnical).
- Ability to read, interpret, and follow written instructions and drawings
- Ability to work in a team environment with little or no supervision.
- Ability to use excellent communication and interpersonal skills when interfacing with EES associates from all levels and functions of the organization.
- Extensive working knowledge of GDP/ISO regulations and requirements.
- Certifications preferred ASQ CQI, ASQ CQT
- Computer skills
- Proficient with MS Office applications
- Proficient with PLM system (WINDCHILL)
- Experience with ERP system (JDEOne current/ SAP S4 Hana future)
