Senior Quality Assurance Technician

Caliberr Staffing; Berlin (CT); On-site; USD 70,000 - 100,000; Full time

Job summary

Caliberr Staffing in the United States seeks a Senior Quality Assurance Technician to uphold the highest standards of precision for medical device components. You will lead inspection efforts, mentor team members, and ensure rigorous regulatory documentation.

Responsibilities include guiding QC personnel, executing incoming, in-process, and final inspections with CMM, vision systems, and comparators, reviewing DHRs, maintaining GDP, and supporting ERP/QMS processes to sustain compliant,

Qualifications

• 5+ years in a regulated manufacturing environment (medical devices, aerospace, or pharma).
• Expertise with precision measurement tools (micrometers, calipers, height gages, optical comparators).
• Ability to interpret complex blueprints and engineering drawings.
• Demonstrated leadership capable of training others and managing team workflows.
• Strong knowledge of ISO 13485, GMP, and regulatory quality standards.
• Proficiency in Microsoft Office and electronic quality management systems.

Responsibilities

• Lead and mentor quality control personnel, providing guidance on inspection techniques and performance expectations.
• Execute comprehensive incoming, in-process, and final inspections using metrology tools like CMM, vision systems, and comparators.
• Review Device History Records (DHRs) and maintain Good Documentation Practices (GDP).
• Utilize ERP and QMS platforms to manage material traceability, nonconformity reporting, and record retention.
• Perform process audits and provide programming support for complex testing methods.
• Drive continuous improvement by evaluating process controls such as SPC and tool life management.
• Collaborate across departments to maintain high production standards while adhering to safety and PPE protocols.

Skills

Regulated manufacturing

Precision measurement tools

Blueprint interpretation

Leadership / training

ISO 13485 / GMP knowledge

ERP / QMS proficiency

Tools

CMM programming

Vision systems

ERP & QMS software

Job description

As a Senior Quality Assurance Technician, you will play a pivotal role in maintaining the highest standards of precision for complex medical device components. You will lead inspection efforts, mentor team members, and ensure rigorous compliance with regulatory documentation to drive manufacturing excellence.

About the Role

As a Senior Quality Assurance Technician, you will play a pivotal role in maintaining the highest standards of precision for complex medical device components. You will lead inspection efforts, mentor team members, and ensure rigorous compliance with regulatory documentation to drive manufacturing excellence.

Responsibilities

• Lead and mentor quality control personnel, providing guidance on inspection techniques and performance expectations.
• Execute comprehensive incoming, in-process, and final inspections using advanced metrology tools like CMM, vision systems, and comparators.
• Ensure total compliance by meticulously reviewing Device History Records (DHRs) and maintaining strict Good Documentation Practices (GDP).
• Utilize ERP and QMS platforms to manage material traceability, nonconformity reporting, and record retention.
• Perform process audits and provide programming support for complex testing methods to improve operational efficiency.
• Drive continuous improvement initiatives by evaluating process controls such as SPC and tool life management.
• Collaborate across departments to maintain flexible, high-quality production standards while adhering to all safety and PPE protocols.

Required Skills

• 5+ years of experience in a regulated manufacturing environment, such as medical devices, aerospace, or pharmaceuticals.
• Expert proficiency with precision measurement tools including micrometers, calipers, height gages, and optical comparators.
• Strong ability to interpret complex blueprints, technical specifications, and engineering drawings.
• Demonstrated leadership skills with the ability to train others and manage team workflows.
• Solid understanding of ISO 13485, GMP, and regulatory quality standards.
• Proficiency in Microsoft Office and electronic quality management systems.

Preferred Skills

• Professional quality certifications such as ASQ CQT or QCI.
• Experience with advanced CMM programming or automated inspection techniques.
• Background in high-precision metal machining or anodizing processes.