Quality Assurance Specialist

About the role

Reports to Quality Team Leader, Quality Operations Leader, Quality Operations Lead or designee and with the objective of maintaining high quality standards for the product manufacturing process and the compliance with the regulatory requirements, supports and maintains 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.

Responsibilities

• 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.
• Handle of non-conformant material or potential non-conformant material.
• In charge of maintaining all material inside the hold cage on control.
• Placing and removal of material on hold.
• In charge of leading stop shipment process for material in the Distribution Centers or Interplants.
• Place and remove material on hold as applicable.
• Coordinate and provide training to associates on inspection and disposition of product.
• Update and maintain training material for inspection and disposition of product.
• Care for practical evaluation for inspection and disposition to associates.
• Update and maintain material for practical evaluation and auto-monitoring.
• Verify completion of operator certification requirements for associates and request operator certification.
• Carry out 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.
• Data Analysis, Process Improvements and Decision Making:
• 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.
• 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.
• Utilize quality and statistical tools to recommend process improvements.
• Train new Quality Specialist at the manufacturing area and QA Specialist duties and responsibilities.
• Coordinate particle count monitoring, per applicable procedures.
• Support Finished Goods Lab as backup, when necessary, for specific duties of QA Finished Goods Technician as required.

Qualifications / Requirements

• A minimum of an Associate Degree is required.
• A minimum of four (4) years of experience in the regulated manufacturing industry is required.
• At least two (2) years of experience in Quality Assurance is preferred.
• PC literacy including MS Office and use of other software and applications is required.
• Verbal and written communication skills in English and Spanish are required.
• Knowledge of QSR's and ISO Standards is required.
• ASQ CQT is preferred.
• ASQ CQA is preferred.
• Availability to work overtime, various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays is required.

Benefits

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.