Manufacturing Quality Control Specialist
About The Position
GoCheck Kids is a mission driven B2B health tech company dedicated to making a significant impact on children's lives by detecting health issues early on. Our innovative technology is revolutionizing the way health issues are identified and addressed, ensuring children receive the care they need at the earliest possible stage. The Manufacturing Quality Control (QC) Specialist is a hands-on role responsible for leading coordination and execution of QC activities at the Manufacturing site and working with Production personnel to ensure product that meets requirements prior to release.
Requirements
- High school diploma/GED plus 3-5 years working experience, within QA/QC at manufacturing site within regulated industry (Medical Device Industry preferred).
- Experience with Inspection processes including Inspection Plans (receiving & final).
- Experience with DHR review and product release.
- Experience with Control of Nonconforming product.
- Working knowledge of Production and Process controls, including Facilities controls.
- Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).
- Technical aptitude with inspection technique and use of inspection tools (e.g., calipers).
- Quality-Focused, Attentive to Detail and Results-Oriented.
- Ability to work independently in fast-paced environment with little supervision.
- Ability to communicate effectively (both written and oral) using English (or local language).
- Team-oriented and responsive to customer needs.
- MS Office proficiency is required, specifically Excel and Word.
Nice To Haves
- Quality Inspector Certification (e.g., ASQ).
- Experience with Equipment controls (CAL/PM).
- Experience with Product Returns processing.
- Experience with CAPA processes including investigational techniques.
- Working knowledge of Equipment Qualifications, Process Validations and Test Methods Validations requirements.
Responsibilities
- Completion of Receiving and Receiving Inspection
- Completion of Final Inspection and final DHR review
- Initiation of NCMR for nonconforming product
- Completion of NCMR dispositions after approval
- Implementation of product hold after approval
- Support the following QA areas per documented procedure requirements: Equipment management, Product Returns processing, Nonconforming Product process management, Product Hold management, Records Storage
- QC support of Design Activities, including, but not limited to: Equipment qualifications, process validations, test method validations and DMR document development (e.g., inspection plans, test instructions, Bill of Materials, pFMEA)
- Design Verification Testing
- Other duties as assigned by VP of Quality and Regulatory or Chief Operating Officer. (e.g., periodic auditing of manufacturing site, as assigned)
Benefits
- Competitive salary, commensurate with experience
- Comprehensive health benefits package
- Opportunity for professional growth and development
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
