Quality Control Specialist

Roles And Responsibilities

• Develop, implement, and maintain quality control procedures, inspection protocols, and quality standards for incoming assemblies and products, ensuring compliance with established inspection requirements and Good Documentation Practices (GDP).
• Review OEM specifications, technical documentation, and repair procedures to develop quality control inspection sheets that align with industry best practices and quality standards.
• Collaborate with technicians to capture lessons learned, identify recurring quality issues, and continuously refine quality control requirements and inspection criteria for individual parts and assemblies.
• Conduct warranty investigations and root cause analyses to identify failure trends, implement corrective actions, and reduce warranty claims while improving overall product quality and reliability.
• Identify, evaluate, and implement continuous improvement initiatives to reduce the Cost of Poor Quality (COPQ), improve operational efficiency, and achieve annual quality performance objectives.
• Conduct inspections, audits, and testing throughout the manufacturing process to verify compliance with product specifications, quality standards, and regulatory requirements.
• Identify, document, and communicate quality issues, and drive the development, implementation, and verification of effective corrective and preventive actions to improve product quality and process performance.
• Perform quality audits and assessments to evaluate compliance with standard operating procedures, quality management system requirements, and applicable regulatory standards, identifying opportunities for continuous improvement.
• Collect, analyze, and interpret quality and operational data to identify trends, uncover root causes, measure performance, and drive continuous improvement initiatives.
• Provide training, guidance, and ongoing support to production teams to ensure a thorough understanding of quality control requirements, consistent adherence to established procedures, and compliance with quality standards.
• Maintain accurate and complete quality records and documentation, including inspection reports, test results, nonconformance reports, corrective actions, and other quality management system records in accordance with established procedures and regulatory requirements.
• Monitor and ensure compliance with quality requirements within the service area, including the control of expired materials, maintenance of calibrated equipment, and proper implementation of Electrostatic Discharge (ESD) handling procedures.

Requirements

• High school diploma or GED required
• Minimum of 2+ years of experience in a quality control role or similar role required
• Manufacturing or relevant industry related or equivalent experience is required.
• Computer/ Data Entry experience is essential
• Strong knowledge of quality control principles and practices, as well as relevant regulatory requirements and standards (such as ISO 13485, ISO 9001, or AS 9100).
• Experience with quality control tools and techniques, such as statistical process control, root cause analysis, and failure mode and effect analysis.
• Detail-oriented mindset with strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in Microsoft Office Suite (Excel) and other quality management software.
• Must be able to pass a background check and drug test prior to starting position.

Preferred

• Medical device industry experience preferred
• Previous medical device assembly experience preferred
• Previous use of microscopes and/or small parts assembly experience a plus

Benefits

• Paid time off
• Healthcare insurance (medical, dental, and vision coverage)
• Accident insurance, critical illness, and hospital indemnity insurance
• Short term (employee paid) and long-term disability (employer paid) insurance
• 401K plan with company matching
• Continuous learning and development - offering opportunities for training, workshops, and certifications