Quality Inspector
Summary
Inspects and tests manufactured products for quality and compliance with standards, documents findings, and troubleshoots equipment issues in a GMP-regulated environment.
Ensures the quality of products through thorough assessment and analyses using specific procedural standards for integrity. The Inspector performs testing, reviews test data, and writes investigations in compliance with Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs).
• Performs inspections of company products to determine conformance with specifications
• Utilizes standard mechanical and electrical instruments, functional gauges and test rigs
• Process associated documentation, including process tags, rework tags and nonconforming material documents
• Analyzes products in compliance with GMPs regulations and SOPs
• Reviews data obtained for compliance to specifications; reports abnormalities
• Completes and maintains appropriate documentation to support testing procedures and comply with GMPs including but not limited to data capture forms, equipment logbooks, and inventory forms
• Conducts internal quality audits
• Calibrates and maintains equipment according to maintenance schedules, GMP requirements, and SOPs
• Identifies and troubleshoots equipment problems
• Assists with creation of new SOPs and/or revision of existing documentation
• Reads, understands, and follows SOPs; complies with current GMP as required
• Maintain supply levels for performance of assigned duties
• Maintains accurate and updated notebooks and records
• Participates in GMP audits • Continuous management and disposition of Defective Material Reporting (DMR) area; identifying defective material, entering information into the current database, and executing containment actions; coordinating with other departments to effectively improve process of DMR items as appropriate
• Reviews product returns, documents issues, and interfaces with various departments to process returns
• Follows all safety regulations
• Performs other related duties as assigned by management
• Utilizes standard mechanical and electrical instruments, functional gauges and test rigs
• Process associated documentation, including process tags, rework tags and nonconforming material documents
• Analyzes products in compliance with GMPs regulations and SOPs
• Reviews data obtained for compliance to specifications; reports abnormalities
• Completes and maintains appropriate documentation to support testing procedures and comply with GMPs including but not limited to data capture forms, equipment logbooks, and inventory forms
• Conducts internal quality audits
• Calibrates and maintains equipment according to maintenance schedules, GMP requirements, and SOPs
• Identifies and troubleshoots equipment problems
• Assists with creation of new SOPs and/or revision of existing documentation
• Reads, understands, and follows SOPs; complies with current GMP as required
• Maintain supply levels for performance of assigned duties
• Maintains accurate and updated notebooks and records
• Participates in GMP audits • Continuous management and disposition of Defective Material Reporting (DMR) area; identifying defective material, entering information into the current database, and executing containment actions; coordinating with other departments to effectively improve process of DMR items as appropriate
• Reviews product returns, documents issues, and interfaces with various departments to process returns
• Follows all safety regulations
• Performs other related duties as assigned by management
• Understanding of manufacturing equipment, assembly process, and safety procedures required
• Experience with assessment and quality improvement processes preferred
• Technical capacity
• Commitment to excellence and high standards
• Excellent written and oral communication skills
• Strong planning, organizational, problem-solving, and analytical skills
• Ability to manage priorities and workflow
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
• Acute attention to detail
• Proven ability to handle multiple projects and meet deadlines
• Working knowledge of data collection, data analysis and evaluation
• Interpersonal savvy; able to collaborate and work closely with others
• Self-motivated, resourceful, and adaptable; able to work independently within team focused environment
• Strong understanding of how to create highly satisfied customer
• Ability to follow established policies and procedures with a safety-first attitude
• Broad level of safety, health, and environmental rules and regulations, policies and procedures
• A top performer who can instill pride of workmanship in themselves and in others
• Working knowledge of Microsoft Office 365 software; SAP experience preferred
• Familiarity with Quality Management Systems, ISO14001, preferred
• Experience with assessment and quality improvement processes preferred
• Technical capacity
• Commitment to excellence and high standards
• Excellent written and oral communication skills
• Strong planning, organizational, problem-solving, and analytical skills
• Ability to manage priorities and workflow
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
• Acute attention to detail
• Proven ability to handle multiple projects and meet deadlines
• Working knowledge of data collection, data analysis and evaluation
• Interpersonal savvy; able to collaborate and work closely with others
• Self-motivated, resourceful, and adaptable; able to work independently within team focused environment
• Strong understanding of how to create highly satisfied customer
• Ability to follow established policies and procedures with a safety-first attitude
• Broad level of safety, health, and environmental rules and regulations, policies and procedures
• A top performer who can instill pride of workmanship in themselves and in others
• Working knowledge of Microsoft Office 365 software; SAP experience preferred
• Familiarity with Quality Management Systems, ISO14001, preferred