Blueprints, Communication Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Datasheets, Detail Oriented, Documentation, ERP (Enterprise Resource Planning), English Language, FDA (Food and Drug Administration), FDA Requirements, ISO (International Organization for Standardization), ISO 9001, Injection Molding, Internal Audit, Lift/Move 50 Pounds, Logistics, Maintain Compliance, Manufacturing, Manufacturing Operations, Microsoft Office, Operational Audit, Operational Support, Organizational Skills, Product Documentation, Production Systems, Quality Assurance, Quality Assurance Methodology, Quality Control, Quality Management, Reduction of Hazardous Substances (RoHS), Regulatory Compliance, Regulatory Requirements, Safety Compliance, Team Player, Vision Comparator
Job Title: Quality Assurance Specialist
Location: Onsite Ansonia, CT
Type: Direct Hire
Salary: $28-32 per hour DOE Plus Excellent Benefits
Position Summary
The Quality Assurance Specialist is responsible for ensuring product conformity through accurate documentation in accordance with company procedures, customer requirements, and regulatory standards. This role supports manufacturing operations through inspection review, audit participation, compliance documentation, and quality system activities while working closely with production, shipping, and quality teams.
Reports To: Quality Assurance Manager
Essential Functions
- Ensure quality documentation, product quality, and product completion are accomplished in accordance with company requirements.
- Assist with routine quality inspections following company procedures and customer specifications.
- Support Material Review Board (MRB) activities as needed.
- Review completed job packets for accuracy, completeness, and compliance.
- Close work orders (Job Travelers) within the ERP system.
- Review and approve incoming inspection documentation.
- Verify material transfers to individual jobs.
- Generate REACH and RoHS compliance documentation to meet customer requirements.
- Monitor label accuracy on presses, grinders, and dryers.
- Maintain Safety Data Sheet (SDS) logbooks for both facilities to ensure compliance with safety regulations.
- Collaborate with the shipping department to generate required customer documentation, including Material Certifications and Certificates of Conformance (COC).
- Participate as a member of the Internal Audit Team.
- Support and participate in all company audits, including Internal, ISO, Customer, FDA, and Third-Party audits.
- Perform other related duties as assigned.
- Provide assistance with various quality department activities and projects as business needs arise.
Qualifications
Required Qualifications
- Working knowledge of ISO 9001 and FDA cGMP requirements.
- Proficiency with ERP/MRP systems.
- Strong English communication and reading comprehension skills.
- Knowledge of quality assurance processes and procedures.
- Basic blueprint reading skills.
- Experience using inspection equipment, including hand gauges and optical comparators.
- Strong attention to detail and organizational skills.
- Proficiency with Microsoft Office applications.
Education
- High School Diploma or equivalent required.
Experience
- Minimum of 5 years of experience in Quality Assurance or a related field.
- Ability to read, understand, and interpret company and customer quality requirements.
Preferred Qualifications
- Experience in a manufacturing environment, preferably within injection molding operations.
- Experience supporting quality systems, audits, and compliance documentation in a production setting.
Physical Requirements & Work Environment
- Work is primarily performed in a manufacturing/production environment.
- Frequent sitting, standing, and walking throughout the workday.
- Occasional climbing, stooping, kneeling, crouching, and balancing.
- Ability to occasionally lift, carry, and balance up to 50 pounds.
- Must possess effective communication and collaboration skills to work cross-functionally with multiple departments.
About Us
Founded in 2010, Top Prospect Group specializes in connecting high-quality candidates with top-tier clients. In 2023, we joined HW Staffing Solutions, expanding our national footprint across manufacturing, engineering, logistics, and technology.
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Top Prospect Group LLC
Top Prospect Group founders and management team offer more than 75 years of combined experience in Information Technology, Creative & Marketing, and Finance & Accounting staffing and solutions. Our fundamental goal is to build successful relationships resulting in accurate job and prospect representations. We meet with those we work with face-to-face to garner a better understanding of candidate or client requirements. By leveraging our experience and market insight, we are able to provide a more consistent recruitment process. Motivated by a partnership philosophy, our staff possesses a deep understanding of how to forge mutually beneficial long-term relationships. We believe in what we do and continuously strive for excellence.
20 to 49 employees
Staffing/Employment Agencies
http://www.topprospectgroup.com/