Manufacturing Quality Control Specialist

About the role

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. 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 meets requirements prior to release.

Responsibilities

• Perform receiving and receiving inspection
• Complete final inspection and final DHR review
• Initiate NCMR for nonconforming product
• Complete NCMR dispositions after approval
• Implement product hold after approval
• Support equipment management, product returns processing, nonconforming product process management, product hold management, and records storage per documented procedures
• Provide QC support for design activities, including equipment qualifications, process validations, test method validations, and DMR document development (e.g., inspection plans, test instructions, Bill of Materials, pFMEA)
• Conduct design verification testing
• Perform other duties as assigned by the VP of Quality and Regulatory or Chief Operating Officer (e.g., periodic auditing of the manufacturing site)

Authorities

• Release received product (after successful inspection) to released inventory
• Release finished devices (after passing DHR final review) to released inventory
• Implement product hold once approved per procedure requirements
• Implement nonconforming product (NCMR)

Competencies

• Strong working knowledge of QA/QC processes in medical device manufacturing
• Experience working with various inspection tools and techniques
• Familiarity with FDA QSMRs and ISO 13485 regulations
• Commitment to purpose-driven work with a strong sense of responsibility for manufacturing products that serve a meaningful mission
• Appreciation for open, transparent communication and a desire to contribute to a collaborative, low-ego team environment
• Comfort executing and documenting work within structured processes and actively contributing to continuous improvement efforts
• Self-directed and dependable with the ability to stay focused, prioritize tasks, collaborate across functions, and proactively solve problems—with judgment to escalate or seek support when needed
• Strong attention to detail, particularly in following documented procedures
• Clear and concise verbal and written communication skills with an ability to document work in English in alignment with quality system requirements
• Understanding of production workflows and downstream impacts, with awareness of how manufacturing quality and productivity affects customer support and satisfaction
• Alignment with company principles emphasizing transparency, curiosity, meaningful work relationships built on care and trust, a bias for action and growth, and a relentless focus on delivering an exceptional customer experience
• Flexible and committed to meeting key deadlines, including occasional overtime to support large customer orders or urgent shipments

Requirements

• High school diploma/GED plus 3–5 years of QA/QC experience at a manufacturing site within a 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 (ability to read and comprehend technical documentation, execute procedures, and understand system documentation)
• Technical aptitude with inspection techniques and use of inspection tools (e.g., calipers)
• Quality-focused, attentive to detail, and results-oriented
• Ability to work independently in a 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
• Proficiency in MS Office, specifically Excel and Word

Preferred Experience

• Quality Inspector Certification (e.g., ASQ)
• Experience with equipment controls (calibration/preventive maintenance)
• Experience with product returns processing
• Experience with CAPA processes including investigational techniques
• Working knowledge of equipment qualifications, process validations, and test method validations requirements