Quality Engineer II Orthopedics ( 2nd Shift)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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Job Description:

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes

We are searching for the best talent for Quality Engineer II Orthopedics ( 2nd Shift) to be in Juarez City.

You will be responsible for:

• 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/correction of process failures when needed.
• Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan
• Develop measurement systems/capabilities destructive tests non-destructive tests for manufacturing processes
• Develop control plans consistent with product classification potential defect types defect frequency severity patient risk process capability process controls etc.
• Develop interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Develop interpret and implement standard and non-standard sampling plans
• Assess effectiveness of measurement tools destructive tests non-destructive tests measurement system analysis.
• Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification potential defect types defect frequency severity patient risk process capability process controls etc. including assessing applying and interpreting acceptance sampling standard for manufacturing data.
• Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
• Partners with R&D and other cross functional partners to ensure the proper application of design controls risk management and the investigation/correction of design
  failures/challenges.
  Supports the development of quality strategies related to the transfer of products materials and components within J&J or externally.
• Supports new product introduction as part of design transfer.

Qualifications / Requirements:

• From 2-4 years related experience.
• Bachelors Degree
• Experience working in both an FDA and European regulatory environment is preferred.
• Experience with implementation of risk mitigation is preferred
• Technical training and experience using Statistics Lean and Six Sigma Methodologies is preferred including Measurement System Analysis SPC DOEs Reliability etc.
• Knowledge of statistical software packages is preferred with the ability to preview graph and analyze data and be able to present data that facilitates/drives decision making.
• The ability to perform hands on troubleshooting and problem solving is preferred. Principles of decision making based on standards requirements and/or procedures.
• Good technical understanding of manufacturing equipment and processes is required.
• Knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.

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