Manager, Quality and Compliance (Medical Device)

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 Quality & Compliance Manager leads all aspects of the company’s Quality Management System (QMS), including compliance with FDA regulations, ISO 13485, and internal standards. This individual owns and operates the quality system, supervises a small team of specialists, and serves as the primary interface with regulators and auditors. The role blends strategic QMS leadership with hands-on execution across CAPA, document control, design changes, supplier management, complaint handling, internal audits, and production quality. 

This is a key cross-functional role working closely with manufacturing, engineering, product development, and executive leadership to ensure both operational quality and regulatory readiness. The Quality & Compliance Manager executes core QMS tasks personally, while also delegating operational tasks to a small team of specialized Quality & Compliance staff (e.g. QC Inspector, Compliance Specialist, etc). This role is highly hands-on in daily quality operations.

The Quality & Compliance Manager is a full-time role based at our manufacturing office in Nashville, TN.

This role reports to the Chief Operating Officer with a high degree of autonomy in leading quality and compliance activities.

Key Responsibilities:

To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily. Other duties may be assigned.

• Lead the development, maintenance, and improvement of QMS procedures and documentation in accordance with FDA QMSR and ISO 13485.
• Manage and execute the CAPA process, including root cause analysis, effectiveness verification, and coordination of the CAPA Review Board (CRB).
• Oversee the Document and Change Control process, including execution of daily tasks for Document/Change Control and Control of Quality Records, and periodic reviews of controlled documents.
• Support design transfer activities by completing Design Transfer deliverables associated with software releases and new product introduction.
  
• Manage the Supplier Quality Management Program, including maintenance of the Approved Supplier List (ASL) and supplier evaluations.
• Oversee and execute the Product Returns processes, including returns dispositioning.
• Management of Nonconforming Product process, including coordination of MRB.
• Ensure compliance with manufacturing-related QMS processes, including management of Production and Process Controls, Equipment Controls, Quality Control Inspections and other Quality Operations processes to ensure on-going compliance at Manufacturing site. 
• Manage the company’s Internal Audit Program, including planning, execution of daily tasks, reporting, and follow-up activities.
• Maintain and administer the company’s Quality Training Program, including development of content and management of training records.
• Supervise Quality and Compliance personnel, providing mentorship, task delegation, and performance feedback.
• Prepare and facilitate periodic Quality Management Review meetings, including data compilation, reporting, coordination, preparation and minutes.
• Serve as the designated Quality Management Representative, ensuring the QMS is effectively implemented, maintained, and reported to top management. This individual has authority to raise compliance concerns directly to Board of Directors.

• Act as the company’s Front Room lead during external audits and inspections by FDA and other External Agencies.
• Participate in or lead complaint handling and postmarket processes including MDR and recall readiness as needed.
• Drive continuous improvement initiatives across the QMS and operational quality processes.
• Perform other quality and compliance duties as assigned by the Chief Operating Officer.

Competencies:

• Expert knowledge of FDA and ISO 13485 quality standards
• Skilled at preparing for and leading audits and inspections
• Hands-on problem solver with CAPA and root cause analysis expertise
• Able to build productive relationships with suppliers and cross-functional teams
• Effective people manager who can mentor and develop team members
• Clear and confident communicator at all levels of the organization
• Organized project manager who thrives in fast-paced environments
• Driven to improve processes and strengthen the Quality Management System
• Focuses on achieving meaningful quality outcomes, not just passing an audit or inspection.
• Ability to travel, but frequency will be rare

Qualifications:

• Bachelor’s degree in Quality, Engineering, Life Sciences, or a related technical field.
• 6+ years of quality and compliance experience within the medical device industry.
• 3+ years of experience with External Agency Interaction, including Front Room leadership
• 3+ years of experience with Quality Management Reviews and Quality Metrics.
• 3+ years’ Audit Experience and Auditor Certification.
• Expert knowledge of FDA QMSR (21 CFR 820) and ISO 13485.
• Proven success in managing a QMS and leading internal and external audits.
• Extensive, hands-on experience with CAPA, document control, supplier quality, complaint handling, and training systems.
• Experience and expertise in developing and implementing QMS procedures and processes.
• Hands-on experience with Design Transfer processes and deliverables.
• Working knowledge of Complaint Handling, MDR and Recall processes.
• Experience supervising or mentoring quality or compliance personnel.
• Technical aptitude including ability to understand and interpret procedures, specifications, and inspection results.
• Incredibly strong written and verbal communication skills, with the ability to lead and influence across functions.
• Ability to interface with top organizational leadership in an effective manner.
  

Preferred Experience:

• Experience with SiMD and/or SaMD, including software verification and validation within a regulated medical device environment.
• Experience developing and conducting QMS/Quality training.
• Experience operating within a small or early-stage medical device company, particularly with 510(k)- exempt devices.
• Experience working with Greenlight Guru
• Comfortable working with cross-functional teams in rapid development or iterative product development environments
• Hands on experience with developing and/or performing equipment qualification, process validation, and test method validations.
• Experience with project management or formal project coordination (e.g., PMP certification or equivalent).
  

Additional Eligibility Requirements:

Employment at GoCheck Kids is contingent upon successfully completing the following pre-employment requirements:

• Background Check: Verification of employment history, education, and other relevant credentials, conducted in accordance with applicable laws.
• Exclusions Screening: Confirmation that the candidate is not listed on any federal or state exclusion lists
• Drug Screening: Pre-employment drug testing, completed in compliance with all applicable state and federal regulations.

Benefits:

• Competitive salary, commensurate with experience
• Comprehensive health benefits package
• Flexible time off policy
• 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.