Responsibilities:

• Define and execute in-process and final QC strategies: Develop comprehensive quality control plans and procedures that encompass all stages of the manufacturing process, from raw material inspection to final product release. This includes establishing acceptance criteria, sampling plans, and testing methodologies to ensure products meet or exceed specified quality requirements.
  

• Lead root cause analysis and drive corrective actions (CAPA): Take ownership of investigating quality issues, identifying root causes through systematic analysis, and implementing effective corrective and preventive actions. This involves leading cross-functional teams in problem-solving efforts, documenting findings, and verifying the effectiveness of implemented solutions to prevent recurrence.
  

• Manage inspection protocols, test plans, and quality documentation: Oversee the creation, maintenance, and execution of detailed inspection protocols, comprehensive test plans, and accurate quality documentation. This includes ensuring that all quality-related records are complete, accurate, and readily accessible, adhering to regulatory requirements and internal standards.
  

• Work with suppliers on incoming part quality: Collaborate closely with suppliers to establish and maintain high-quality standards for incoming components and materials. This involves defining quality requirements, conducting supplier audits, monitoring supplier performance, and addressing any quality issues to ensure the integrity of the supply chain.
  

• Maintain compliance with ISO and FDA standards (as applicable): Ensure ongoing compliance with relevant international standards, such as ISO 9001 and ISO 13485, as well as applicable regulatory requirements, such as those set forth by the Food and Drug Administration (FDA) for medical devices. This includes participating in audits, implementing necessary procedures, and maintaining a state of audit readiness.
  

Requirements

• 5–8 years in QC or QA roles in medical devices, wearables, or electronics: Possess a minimum of 5 to 8 years of progressive experience in Quality Control or Quality Assurance roles within the medical device, wearable technology, or electronics manufacturing industries. This experience should demonstrate a strong understanding of quality management principles and practices within a regulated environment.
  

• Knowledge of statistical process control and quality tools: Demonstrate a solid understanding and practical application of statistical process control (SPC) methodologies and various quality management tools, such as control charts, Pareto analysis, fishbone diagrams, and failure mode and effects analysis (FMEA).
  

• Familiarity with ISO 9001, ISO 13485, or similar: Possess a strong working knowledge of ISO 9001 and ISO 13485 quality management system standards, or comparable industry-specific quality standards. Experience with the implementation and maintenance of these standards is highly desirable.
  

• Experience with precision components and high-mix low-volume production: Have hands-on experience working with precision-engineered components and managing quality control processes in a high-mix, low-volume production environment. This includes understanding the unique quality challenges associated with such manufacturing operations.