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Quality Assurance Specialist, 1st, 2nd and 3rd Shifts (3 positions)-2996130718
Description
Ethicon LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Quality Assurance Specialist for the 1st, 2nd and 3rd Shift, for the facility located in San Lorenzo, PR.
The Ethicon LLC San Lorenzo, Puerto Rico manufacturing facility hosts over 1,000 associates dedicated to producing world-class medical devices to safely and effectively meet the needs of patients from all continents. Ethicon LLC, develops and markets products within three divisions: Ethicon Products for precise wound closure and tissue repair, Ethicon Women’s Health & Urology for minimally invasive women’s health procedures, and Johnson & Johnson Wound Management for Hemostats and advanced wound care.
Under the direction of the Quality Operations Manager or the Quality Operations Engineer and with the objective of maintaining high quality standards for the product manufacturing process and the compliance with the regulatory requirements, supports and maintain OPCERT program, performs data analysis to support process improvements and decision making and performs other functions to support the Quality Assurance Department at Ethicon LLC. Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written specifications and quality standards. Support cost improvement projects at plant level and prepare reports (using the computer system) as assigned. Coordinate and provide training to associates on inspection and disposition of product. Update and maintain training material for inspection and disposition of product. Coordinate and perform practical evaluation for inspection and disposition to associates. Update and maintain material for practical evaluation and auto-monitoring. Verifies completion of operator certification requirements for associates and request operator certification. Perform audits and support the internal audit program. Maintain knowledge of all procedures, changes to specifications and new regulations related to the area of responsibility. Support associates on defect awareness and specification requirements. Exercise initiative, leadership and decision making to solve quality-related issues with other departments’ organization members and other Ethicon sites’ organization members. Perform data analysis and recommend disposition of material. Use of Statistical Process Control knowledge to make decision on the acceptance/rejection of the product/process. Perform batch record review for product release. Evaluate and make decisions on day to day manufacturing QA related issues. Participate in non conformances’ investigations and root cause analysis. Evaluate and approve product control and disposition to determine if product is according to the requirements and Quality Systems Regulations. Responsible for coordination of hold material and track and report of hold trends. Support Engineering and QA Departments in projects and validation activities. Submit changes and support implementation of changes in the documentation system. Support the effective implementation of programs that help improve the overall quality of product and process within area of responsibility. Utilize quality and statistical tools to recommend process improvements. Train new Quality Specialist at the manufacturing area and QA Specialist duties and responsibilities. Perform particle count monitoring, per applicable procedures. Coordinate dose audit monitoring samples, per applicable procedures. Support Finished Goods Lab as back up, when necessary... Perform other duties as required by QOE and department manager. Participate in safety initiatives within the facility. Be aware of, and comply with Company’s Safety Policies. Ensure and practice safe working conditions. Properly use of all personnel protective equipment, if required, to safely perform the job as necessary.
Qualifications
A minimum of Associate’s Degree is required, in Sciences or Engineering will be preferred. At least one to (1) to three (3) years of experience in Quality Assurance functions is required. Good Manufacturing Practice (GMP) knowledge related to QS Regulation 21 CFR Part 820 and ISO 13485 is required. American Society for Quality (ASQ) Certification, Certified Quality Technician (CTQ), and Certified Quality Auditor (CQA) is preferred. Candidate must have good knowledge in computer applications such as Microsoft Office (Word, Outlook, and Power Point) and must be proficient in the use of Microsoft Excel. Knowledge in Minitab will be highly preferred. Good communication skills at all levels within the organization including management level is required. Fully Bilingual (Spanish & English) Read, Written and spoken is required. Candidate must be available to work on all three shifts of the operation. Physical requirements of the position include stand, walk, carry and move cases, kneel, type and be stand up for long periods. Vision abilities required for this job includes close vision. Availability to travel ten percent (10%) inside and outside of Puerto Rico is required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Puerto Rico-San Lorenzo
Organization: Ethicon Puerto Rico LLC (7596)
Relocation: Eligible
No
Travel:Yes, 10 % of the Time
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Quality Assurance Specialist, 1st, 2nd and 3rd Shifts (3 positions)-2996130718
Description
Ethicon LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Quality Assurance Specialist for the 1st, 2nd and 3rd Shift, for the facility located in San Lorenzo, PR.
The Ethicon LLC San Lorenzo, Puerto Rico manufacturing facility hosts over 1,000 associates dedicated to producing world-class medical devices to safely and effectively meet the needs of patients from all continents. Ethicon LLC, develops and markets products within three divisions: Ethicon Products for precise wound closure and tissue repair, Ethicon Women’s Health & Urology for minimally invasive women’s health procedures, and Johnson & Johnson Wound Management for Hemostats and advanced wound care.
Under the direction of the Quality Operations Manager or the Quality Operations Engineer and with the objective of maintaining high quality standards for the product manufacturing process and the compliance with the regulatory requirements, supports and maintain OPCERT program, performs data analysis to support process improvements and decision making and performs other functions to support the Quality Assurance Department at Ethicon LLC. Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written specifications and quality standards. Support cost improvement projects at plant level and prepare reports (using the computer system) as assigned. Coordinate and provide training to associates on inspection and disposition of product. Update and maintain training material for inspection and disposition of product. Coordinate and perform practical evaluation for inspection and disposition to associates. Update and maintain material for practical evaluation and auto-monitoring. Verifies completion of operator certification requirements for associates and request operator certification. Perform audits and support the internal audit program. Maintain knowledge of all procedures, changes to specifications and new regulations related to the area of responsibility. Support associates on defect awareness and specification requirements. Exercise initiative, leadership and decision making to solve quality-related issues with other departments’ organization members and other Ethicon sites’ organization members. Perform data analysis and recommend disposition of material. Use of Statistical Process Control knowledge to make decision on the acceptance/rejection of the product/process. Perform batch record review for product release. Evaluate and make decisions on day to day manufacturing QA related issues. Participate in non conformances’ investigations and root cause analysis. Evaluate and approve product control and disposition to determine if product is according to the requirements and Quality Systems Regulations. Responsible for coordination of hold material and track and report of hold trends. Support Engineering and QA Departments in projects and validation activities. Submit changes and support implementation of changes in the documentation system. Support the effective implementation of programs that help improve the overall quality of product and process within area of responsibility. Utilize quality and statistical tools to recommend process improvements. Train new Quality Specialist at the manufacturing area and QA Specialist duties and responsibilities. Perform particle count monitoring, per applicable procedures. Coordinate dose audit monitoring samples, per applicable procedures. Support Finished Goods Lab as back up, when necessary... Perform other duties as required by QOE and department manager. Participate in safety initiatives within the facility. Be aware of, and comply with Company’s Safety Policies. Ensure and practice safe working conditions. Properly use of all personnel protective equipment, if required, to safely perform the job as necessary.
Qualifications
A minimum of Associate’s Degree is required, in Sciences or Engineering will be preferred. At least one to (1) to three (3) years of experience in Quality Assurance functions is required. Good Manufacturing Practice (GMP) knowledge related to QS Regulation 21 CFR Part 820 and ISO 13485 is required. American Society for Quality (ASQ) Certification, Certified Quality Technician (CTQ), and Certified Quality Auditor (CQA) is preferred. Candidate must have good knowledge in computer applications such as Microsoft Office (Word, Outlook, and Power Point) and must be proficient in the use of Microsoft Excel. Knowledge in Minitab will be highly preferred. Good communication skills at all levels within the organization including management level is required. Fully Bilingual (Spanish & English) Read, Written and spoken is required. Candidate must be available to work on all three shifts of the operation. Physical requirements of the position include stand, walk, carry and move cases, kneel, type and be stand up for long periods. Vision abilities required for this job includes close vision. Availability to travel ten percent (10%) inside and outside of Puerto Rico is required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Puerto Rico-San Lorenzo
Organization: Ethicon Puerto Rico LLC (7596)
Relocation: Eligible
No
Travel:Yes, 10 % of the Time
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.