A Quality Inspector inspects and evaluates products according to company quality control standards. Inspects goods or packaging in a production or manufacturing facility.
The Quality Assurance & Quality Control Specialist is a hands-on quality professional responsible for ensuring that materials, components, in-process production, and finished products meet established specifications, quality standards, customer requirements, and applicable regulatory requirements. This position combines Quality Assurance, Quality Control Inspection, Product Release, and Manufacturing Floor Quality responsibilities. The individual will perform and oversee inspections, review manufacturing and quality records, support lot release activities, identify and investigate quality issues, and provide real-time quality support to production operations.
ESSENTIAL FUNCTIONS/DUTIES
1.
PRODUCT QUALITY RELEASE
Perform and/or support the final quality review and release of manufactured product in accordance with approved procedures and specifications. Review Lot Manufacturing Records, inspection records, test results, certificates, production documentation, and other required quality records for completeness and accuracy. Verify that required inspections, tests, production steps, and documentation have been completed prior to product release. Determine whether product meets established acceptance criteria and release requirements. Approve product for release when all applicable quality requirements have been satisfied. Place product on quality hold when requirements have not been met or when additional investigation is required. Escalate questionable or nonconforming product to the QA Release Supervisor/VP Quality or appropriate management. Participate in investigations when product cannot be released due to quality, documentation, process, or specification issues. 2.
QUALITY CONTROL INSPECTION
Perform Incoming Quality Control (IQC), In-Process Quality Control (IPQC), and final inspection activities. Inspect raw materials, components, molded parts, assemblies, and finished products using established inspection procedures and specifications. Document inspection results accurately and completely. Identify and communicate nonconforming materials, components, assemblies, and finished products. Monitor production processes for compliance with approved procedures and specifications. 3.
ON-FLOOR QUALITY ASSURANCE
Provide daily quality presence and support on the manufacturing floor. Monitor molding, packaging, filling, and other manufacturing processes for adherence to approved procedures and work instructions. Work directly with Manufacturing personnel to identify and correct quality issues. Verify that process controls and inspection requirements are being followed. Assist with containment activities when quality issues are identified. Support root-cause investigations and implementation of corrective actions. 4.
QUALITY SYSTEM SUPPORT
Support compliance with
ISO 13485, FDA
GMP/QSR, and applicable company quality system requirements. Support internal and external audits. Assist with corrective and preventive action activities. Support nonconforming material/product control and Material Review Board (MRB) activities. Participate in customer complaint and returned goods investigations as assigned
KEY WORKING RELATIONSHIPS
INTERNAL:
Must work effectively with Operations, Quality, and other departments. The position must be able to communicate quality requirements and concerns clearly and professionally while maintaining independence and objectivity in quality decisions. The individual must be comfortable working directly with production personnel on the manufacturing floor and must be willing to stop, hold, or escalate product when established quality requirements are not met.
EXTERNAL
May communicate with suppliers, outside testing or sterilization providers, customers, and other external parties regarding quality issues, inspections, documentation, and product requirements as directed by management.
SUPERVISORY RESPONSIBILITIES
No direct supervisory responsibility is required.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS
Required Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical field; equivalent combination of education and experience may be considered. Minimum 3 years of combined Quality Assurance and Quality Control experience in a manufacturing environment. Experience performing or supporting final product/lot release. Experience performing incoming, in-process, and final inspection. Experience working directly with manufacturing personnel in a production-floor quality role. Strong computer skills and proficiency with Microsoft Word and Excel. Strong written and verbal communication skills. Strong attention to detail and ability to maintain accurate quality documentation. Demonstrated ability to make objective quality decisions based on specifications, procedures, and documented evidence. Strongly Preferred Experience in medical device, medical products, disposable products, or other regulated manufacturing. Minimum 3 years of experience with
ISO 13485.
Minimum 3 years of experience with
FDA GMP/QSR
requirements.
Job Type:
Full-time Pay:
From $50,000.00 per year
Benefits:
401(k) Dental insurance Health insurance Health savings account Life insurance Paid time off Vision insurance
