Quality Control
Process Improvement
Statistical Analysis
Root Cause Analysis
Auditing
Documentation
Problem Solving
Attention to Detail
Team Collaboration
Compliance
Manufacturing Standards
Continuous Improvement
Assemble and/or repair product assemblies and components by following work orders, engineering drawings, standard operating procedures (SOPs), and verbal instructions.
Perform manufacturing processes such as bending, tacking, welding, tweaking, leak testing, and component assembly in accordance with approved specifications.
Operate production equipment, test fixtures, electronic measuring instruments, and leak detection equipment safely and effectively.
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• Minimum SPM qualification or equivalent technical qualification.
• Previous experience in a cleanroom or manufacturing environment.
• Ability to read and interpret engineering drawings
blueprints
and work instructions.
• Attention to detail to identify product defects and maintain high-quality standards.
• Ability to stand and perform repetitive tasks for extended periods while working in a cleanroom environment.
• Comfortable in wearing full PPE - cleanroom garments
gloves
face mask
safety glasses
and other required PPE throughout the shift.
Candidates should possess strong skills in Quality Assurance and Quality Management, including developing, implementing, and maintaining quality systems and policies.
Candidates should possess skills in Quality Control, with experience in product inspection, process monitoring, and verification of compliance with specifications and standards.
Candidates should possess skills in Quality Auditing, including internal audits, documentation review, and support for external and certification audits.
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Ensures assigned operation adheres to GMP/GDP/GDPMD requirements, standard operating procedures, secondary Repacking Work Instruction (RWI), batch packaging record and the quality standards set.
Review and maintain quality assurance documents and records in compliance with document control procedures and cGMP requirements.
Ensures only current version of RWIs are used as reference by the interested parties.
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Lead and continually improve the company's Quality Management System (QMS), ensuring compliance with ISO 9001, ISO 14001, BRC and customer-specific standards.
Manage quality performance across the manufacturing process, including inspections, testing, process controls and corrective actions.
Lead customer complaint investigations, root cause analysis and CAPA activities to ensure timely resolution and continuous improvement.
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Ability to investigate production issues, handle customer complaints, conduct root cause analysis, identify trends, and implement Corrective and Preventive Actions.
Proven experience in supervising team members and managing daily QA operations.
Able to work effectively with cross-functional teams, particularly production team.
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Lead and manage day-to-day Quality Control activities across machining, electropolishing (EP), and valve assembly operations.
Ensure effective implementation of incoming, in-process, and final inspection activities in accordance with quality plans, engineering drawings, specifications, and customer requirements.
Ensure inspection methods, sampling plans, and acceptance criteria are consistently applied throughout manufacturing.
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Assist in implementing, maintaining, and continuously improving quality control procedures, standards, and documentation.
Prepare, review, and update inspection records, including raw material, packaging material, and finished product inspection forms, labels, and packaging documentation.
Perform daily QC administrative activities, including issuing QC Pass stickers for approved raw materials, packaging materials, and finished products.
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Quality engineers define quality standards for the creation of products or services. They check to make sure the products and services are in compliance with the quality standards and they coordinate quality improvements.
Basic computer knowledge like Microsoft Excel / Word
Maintain and coordinate the lab technician partnership and training systems.
Provide process improvement support, specialized testing, training, audit systems, analyze data, identify trends, troubleshoot, corrective action and communication regarding processing data, final product and wastewater.
Assess quality parameters and systems including cross checks, raw materials, calibration, maintenance, procedures, food safety, training, auditing and oversight of analytical testing.
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