Lead, Quality Engineering

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

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Aurangabad, Maharashtra, India

Job Description:

SECTION 1: JOB SUMMARY*

Lead Quality Engineering adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects. Work is generally expected to result in the development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes

SECTION 2: DUTIES & RESPONSIBILITIES*

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

• Ensure compliance with applicable regulations and policies including local and international standards.
• Improve overall efficiency of the processes through use of Process Excellence, Lean principles, and Data analysis.
• 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.
• This individual will function as a quality representative on multi-functional teams in matters relating to Quality Engineering.
• Review/analyze whether current product and processes (including actions or decisions conducted) are complying to MDR 2017, ISO 13485 and other applicable regulations / standards.
• Supports the development of quality strategies related to the transfer of products, materials, and components within J&J or externally. Supports new product / process / equipment introduction as part of design transfer.
• Support NCR / CAPA/ Complaints/ Internal Audit/ External Audit process.
• Support the Quality Systems used to improve product quality, process and customer satisfaction.
• Make recommendations to management regarding ways to improve Quality and Manufacturing processes in support of current applicable regulations and standards.
• Responsible for communicating business related issues or opportunities to next management level.
• 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

• 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.

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

• Develop measurement systems/capabilities, destructive tests, non-destructive tests for new product / process, if any.
• 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.
• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard / regulation.
• 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
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Ensures effective quality strategies are created for the validation of test methods, process and design of new product / process.
• Shall act as backup for Change Management, Complaint Management, batch release , QSMR and IPQA processes.
• 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.
• Performs other duties assigned as needed.

2.1. AUTHORITIES

• Review and approval of validation documents for manufacturing, utilities / facilities, and

• microbiology functions.

• Approve IQ, OQ, PQ, TMV or Software Validation.
• Review and approval of documentation of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.
• Review and approval in QMS for tasks associated with SAP changes.

SECTION 3: EXPERIENCE AND EDUCATION*

• A minimum of a bachelor's degree, preferably in Engineering or Pharmacy or related technical field.

• Generally, requires 8 to 10 years of related experience.

• Experience working in both an FDA and regulatory environment is preferred.
• This position will require relevant experience working in manufacturing/operations environment.

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Strong 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. The ability to think on the feet and providing sound judgment is highly desired.
• Good technical understanding of manufacturing equipment and processes is required.
• Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
• A thorough understanding of GMP / ISO 13485 regulations is preferred

SECTION 7: RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS

• This position shall interact with all the base business functions and if required may interact with global teams.
• This position reports to Manager Quality Operations.

SECTION 8: LOCATION & TRAVEL REQUIREMENTS

• Primary location of the position is Ethicon, Aurangabad site.

Generally, this position is site specific, and no travel is associated. However, as per business needs travel