Executive Quality Engineering

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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The Quality Engineering Executive is responsible for ensuring product quality regulatory compliance and effective quality system implementation for manufacturing operations. The role supports risk management product master data governance inspection controls and continuous improvement in compliance with global medical device regulations.

Under general direction and in accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position is responsible for following:

• Ensure compliance of Quality Engineering Operations with applicable regulations and policies including local and international standards.

• Improve overall efficiency of the Quality Engineering through use of Process Excellence Lean principles and Data / Statistical analysis.

• Evaluate and analyze statistical and data analysis for projects involving the design development or validation of new or existing products and processes.

• Support in projects for New Equipment or New Product / Process.

• Support in execution of design verification and validation activities.

• Support in implementation of CIP Projects.

• Observe & promote all regulatory requirements as defined per applicable regulation rules & procedures established by the company and notified any violation or deviation to the immediate supervisor or appropriate authority.

• Creation and Revision of GxP procedures using change management system.

• Support in validation execution and review for product process and utilities

• Support in investigation of non-conformities root cause analysis and action completion

• Participation in internal / external audits and compliance of the audit observations findings.

• Review/analyze whether current product and processes (including actions or decisions conducted) are complying to standards ISO13485 and other applicable regulations / standards.

• 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.

• Ensure that customer CTQs are known and adequately addressed in control plan.

• Develop control plans consistent with product classification potential defect types defect frequency severity patient risk process capability process controls etc. for new product / process.

• Develop interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk for new product/process.

• Assess the need for risk mitigation techniques given product classification potential defect types defect frequency severity patient risk process capability process controls etc. Determine effectiveness of these techniques on previously implemented improvements.

• Review and approval of validation documents for manufacturing utilities / facilities and microbiology functions.

• Perform and maintain risk management activities in compliance with ISO 14971 including pFMEA.

• Manage and approve product master data (BOMs routings specifications inspection plans) in ERP/PLM systems.

• Ensure to manage product master data activities (e.g. MDM) end to end with compliance to regulatory requirements throughout the product lifecycle.

• Define and apply statistical acceptance sampling plans using applicable AQL-based standards.

• Review and approve facility and utility qualification documents (IQ/OQ/PQ) including cleanrooms and HVAC.

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