Quality Engineer I

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Ciudad Juarez, Mexico

Job Description:

About MedTech

Qualifications / Requirements

• Bachelor’s in engineering: Mechanical, Electrical, Industrial or applicable science.
• 0 to 2 years of work experience or demonstrated performance.
• Statistics knowledge
• Use of computer packages.
• Ability to communicate in English, orally and in writing.
• Knowledge of engineering fundaments.
• Knowledge of the Product Risk Management / process (FDA and ISO regulations) is preferable.
• Ability to perform “active involvement” in the solution of problems and resolution problems, preferable. Capacity to solve problems by providing good judgment, highly desired.
• CQA certification (preferably.

You will be responsible for:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines.

• Revision / analysis of the effectiveness of PCDA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs. Compliance / Regulatory
• Revises / analyzes if the current products and processes (including taken actions or decisions) comply with the regulations, such as QSRs, ISO 13485, etc. including providing support during internal and external audits.
• Participates in preparation activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.).
• Responds to internal or external audit observations related to the function of quality engineering.
• Establishes and properly maintains the required documentation of quality assurance activities and/or quality systems
• Performs periodical audits of the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS.
• Checks the audits results of the area ton ensure that the corrective and preventive actions are adequate. Product quality, Control and Disposition and Performance Standards
• Conducts or supports investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs) and customer complaints. Escalation of quality problems when applies.
• Supports the analysis of the products related to customer complaints, to determine failure modes.
• Responsible and owner of the identification of material, material segregation, classification of the types of defects, including the successful application of these techniques in the day-to-day in manufacturing.
• Analyzes / revises the effectiveness of preventive and corrective actions. Product Grading / Process
• Revises, approves, executes IQ, OQ, PQ, TMV or Software Validation.
• Maintains and periodically revises the CTQs in the manufacturing process to guarantee the continuous satisfaction of the customer.
• Provides support in the revision and maintenance of PEMEAs, Quality control plans, process instructions and additional manufacturing documents.
• Develops, interprets and properly implements process monitoring and control methods consistent with the process/product risk level.
• Evaluates and interprets common variation causes vs special in the manufacturing process and determine the adequacy of the current process limits.
• Evaluates the needs of risk mitigation techniques given the classification of the product, potential types of defects, defect frequency, severity, risk to the patient, process capacity, process control, etc.
• Determines the effectiveness of these techniques in the previously implemented improvements.
• Responsible and owner of the risk assessment process including the realization, documentation, revision or maintenance of the current risk and risk analysis documentation such as FMEA of the process given the changes in the product/process. Strategic
• Collaborates with other quality leaders to identify the quality engineering abilities required and competences to allow the execution of the strategic vision. People
• Provides supervision, mentoring, coaching, performance revision, development plans and succession planning for others (when applies).
• Responsible for communicating business related issues or opportunities to next management level
• 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 o Performs other duties assigned as needed

 

 

Required Skills:

 

 

Preferred Skills: