Auris Health

Auris Health

Quality Assurance
Mexico City, Mexico
Posted on Tuesday, September 12, 2023


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Please visit https://www.jnjmedicaldevices.com/es-419 for more information.

Ethicon, Wound Closure and Repair is a trusted, the worldwide leader in medical devices company that commits to advanced surgery and improves lives every single day. We are qualified as one of the top best places 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

We are searching for the best talent for Quality Operations Lead (Manager) to be in Ciudad Juarez.

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:The Quality Laboratory Leader plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates. Supervises the daily activities of the quality assurance inspection, monitoring & test. Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Trains, plans, schedules, and assigns work, appraises performance, and resolves problem. Tracks quality investigations and process deviations and follows up to ensure corrective action has been taken. Investigates nonconformance as they pertain to the manufacturing and testing of company products.

Business Improvements

Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.

Conduct benchmarking with external companies or internal sites to develop more effective methods for improving quality

Coordinates in-depth inspections of interdepartmental facilities and systems.

Lead implementation of continuous improvement projects or act as subject matter expert for Inspection, Micro, Envirionmentaland testing techniques


Review/analyze whether current product and processes (including actions or decisions conducted) comply to standards such as the QSRs, ISO 13485, etc.

Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.

Actively participates in internal audits, management review and other activities covered under Ethicon Quality Manual, Policies and Procedures.

Reports inspection findings to department and upper management in a timely fashion.

Assists with conducting and developing site good manufacturing process training.

Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards. Experience with FDA and ISO inspections and registration is a plus.People

As applicable, provides supervision, mentoring, coaching, performance review, and developmental plans for others.

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 applicableProduct Quality, Control & Disposition and Performance Standards

Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.Conduct validation of new processes and products (PQ); establishment of criteria for success.

Work on project teams providing sterilization/micro expertise to help build internal knowledge and aid in business decision making.

Provide technical support for any non-conformance, product disposition and CAPA.

Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001)

Acts as the site point of contact for sterilization and micro technical inquiries from Ethicon Manufacturing and External Manufactures

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

Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing. Analyze/review effectiveness of preventive andcorrective actions. Review root cause investigation according to an established process.

Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.

Production/Process Controls

Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correctionof process failures when needed.

Plans, conducts, and directs engineering projects or studies including complete projects requiring advanced knowledge of sterilization and/or microbiology.

Responsible for the daily sterilization/microbiology oversight; including review of deviations and corrections, and trend assessments.

Responsible for the Environmental Monitoring program for the site.

Provide technical support and assess change control activities impacting sterilization process and microbiology activities at the site.

Assess impact of product/process change control for sterilization.

Establish qualification criteria for external sterilization contractors and micro labs (where applicable).

Conduct EO cycle re-qualifications.Perform periodic product EO residual analysis.Monitor bioburden program.

Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.

Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.

Approves changes to documentation and processes.

Provides microbiology support for the manufacturing site (supports investigations related to environmental excursions, validation of new CME areas, and other micro related investigation support)


  • University Bachelor’sDegree required in Science, Engineering, Bio Medical or related field.
  • 4-6 years related experience
  • Refer to Table A for Education and Job Experience for each level.
  • This position will require relevant experience working in Laboratory and offices environment.
  • A minimum of a bachelor’s Degree, preferably in Engineering/Scienceor related technical field
  • The Quality Laboratory Leader, manage and directs Laboratory Dayto day activities and his staff, coordinate or executeprojects or studies that requires advanced knowledge of a specialized field. They apply comprehensive and diverse knowledge of engineering or science principles and practices within broad assignment areas.
  • They may coordinate and direct activities of technical support staff and are responsible for technical development of assigned staff.