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As an Operations Quality Team Manager, you will lead Q&R activities in the system plant as a PQE team manager. You will be responsible for driving product quality improvements by leveraging statistics and data analysis techniques to enhance processes. Your role will involve close collaboration with production, manufacturing engineering, and suppliers to ensure process control, quality assurance, effective failure analysis, and continuous improvement.
Your role:
Provide clear vision and strategy for the PQE team, ensuring alignment with organizational quality goals.
Build and develop the capabilities of the quality team, fostering a culture of continuous improvement and collaboration.
Lead MRB activities, periodic quality reviews, and provide actionable insights.
Lead real-time manufacturing line investigations, identify root causes of issues, and ensure the implementation of corrective actions through comprehensive reporting and follow-up.
Implement and monitor production and process controls, including Process Validation (PV), Equipment Qualification (EQ), Control Plans, and pFMEA.
Maintain compliance with ISO 13485, FDA regulations, and other relevant standards.
Prepare for and support external audits (regulatory, customer) and perform internal pre-audits.
Act as a liaison between R&D and Operations to ensure a smooth transition during NPI and change management And work closely with Production, Supply Chain, and Manufacturing Engineering to improve overall quality performance.

The Product Quality Engineer drives product quality improvement activities, using statistics and data analysis techniques to improve processes. works with production, manufacturing engineering and suppliers in the areas of process control, quality control and assurance, data collection, failure analysis, corrective actions, reporting for early detection and correction and continuous improvement. Responsible for real time investigation of failures, finding root causes, issuing summarizing report and following-up corrective actions implementation.
Your role:
Manages and follows-up quality activities.
Participate and lead real time manufacturing line investigations to identify cause and containment actions. Work with Production, Supply and Manufacturing Engineer personnel.
Interpret manufacturing outputs and customer inputs, define problems, collect data, establish facts, and draw valid conclusions.
Select and apply quality procedures and methods, appropriate inspection strategy and statistical techniques.
Establish and monitor quality/process control for high risk parts and high risk suppliers.
Create and administer an effective closed-loop corrective action program.
An active member on the production release of new products, responsible for quality plan preparation.
Plan and participate in internal manufacturing audits and assessments as a co-auditor.
Participate in the Material Review Board process to dispose off rejected material..

we are looking for a Quality Engineer.
Quality Engineer is responsible for identifying, analyzing, and correcting failures in products and processes. This role involves close collaboration with Development, Engineering, Production, and Customer service teams to ensure product and service quality.
Responsibilities:
FRACAS Management
Conduct failure analysis for products and processes.
Recommend and implement corrective actions to resolve identified failure modes.
Develop and implement quality control processes for continuous improvement.
Collaborate with cross-functional teams (e.g., design, manufacturing, quality) to understand the issues.
Prepare failure analysis reports and present findings to management.
Follow up on the effectiveness of corrective actions and make adjustments as necessary.
Participate in internal and external Quality audits.
Support the approval processes for new products.
Maintain detailed reports of failure investigations, findings, and corrective actions taken.
Identify opportunities for process or design improvements based on failure trends.
Analyzing Quality trends: Quality Yield , KPIs , CoPQ (Costs of Poor Quality), Customers Rating, RMA, ,Quarterly data analysis for QBR
Investigate and analyze product failures, identifying root causes using techniques such as root cause analysis (RCA), fault tree analysis (FTA), or failure mode and effect analysis (FMEA).