Manufacturing Quality Control Specialist

Job Description

Job Description

About Us:

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.

Position Overview:

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.

Key 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)

Authorities:

• Release of received product (after successful inspection) to released inventory
• Release of finished devices (after passing DHR final review) to released inventory
• Implementing product hold once approved per procedure requirements.
• Implementing 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 ISO13485 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.
• Comfortable 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 the 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 an awareness of how manufacturing quality and productivity affects customer support and satisfaction.
• Alignment with company principles, which emphasize transparency and 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 in order to support large customer orders or urgent shipments.
  

Qualifications:

• 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.

Preferred Experience:

• 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.

Benefits:

• Competitive salary, commensurate with experience
• Comprehensive health benefits package
• Opportunity for professional growth and development

Join us in our mission to make a difference in children's lives and help shape the future of healthcare.