Position SummaryThe Senior Quality Technician ensures calibration activities, Device History Record (DHR) reviews, and manufacturing documentation comply with FDA Quality System Regulations, ISO 13485 requirements, and internal quality procedures. This role serves as the subject matter expert for calibration activities and supports manufacturing, engineering, facilities, and quality teams in maintaining equipment traceability, audit readiness, and compliant product release documentation.
The Senior Quality Technician owns and maintains the site-wide calibration program, coordinates calibration vendors and maintenance activities, supports impact assessments, and performs detailed DHR reviews to ensure products meet all quality and regulatory requirements prior to release.
ResponsibilitiesQuality / ComplianceSupports quality system compliance activities related to calibration control, manufacturing documentation review, traceability, audit readiness, product release, and regulated quality operations within a medical device manufacturing environment.
Responsibilities include:
- Own and maintain the company's calibration master list and calibration system.
- Schedule, track, and coordinate calibration activities for all required equipment.
- Review calibration certificates for accuracy, tolerance requirements, and compliance standards.
- Ensure proper equipment labeling and calibration status identification.
- Maintain calibration records and supporting documentation within the eQMS.
- Monitor calibration metrics and support management review activities.
- Manage out-of-tolerance events and support impact assessments.
- Serve as the calibration subject matter expert during internal and external audits.
- Support continuous improvement initiatives related to measurement systems and compliance.
- Review Device History Records (DHRs) for completeness, accuracy, and compliance prior to product release.
- Verify manufacturing records, inspection results, traceability requirements, and documentation approvals.
- Escalate discrepancies, place lots on hold when necessary, and support resolution activities.
Manufacturing / OperationsSupports manufacturing operations through calibration coordination, maintenance-related quality activities, DHR review, and product release support to ensure compliance with production and regulatory requirements.
Responsibilities include:
- Coordinate calibration vendors, service schedules, equipment pickup, and return activities.
- Establish calibration requirements and intervals for new equipment.
- Partner with Facilities, Manufacturing, Engineering, and Quality teams to ensure equipment remains compliant and production-ready.
- Support maintenance and repair activities requiring recalibration assessments.
- Maintain documentation linkage between maintenance activities and calibration records.
- Assist with equipment status control and segregation of nonconforming equipment.
- Support audit readiness and manufacturing documentation compliance across operations.
Minimum Job RequirementsEducation and Experience- High school diploma or equivalent required.
- Associate degree in Engineering Technology, Quality, Manufacturing, or related technical field preferred.
- 6+ years of experience in a regulated manufacturing environment (medical device preferred) required. Equivalent combinations of education and relevant experience may be considered.
- Experience managing calibration systems and working with third-party calibration vendors required.
- Familiarity with ISO 13485 requirements related to monitoring and measuring equipment and DHR requirements required.
- Experience with inspection tools (calipers, micrometers, height gauges, torque testers, pin gauges, thread gauges, etc.) preferred.
- Understanding of traceability and tolerance requirements preferred.
- Experience with eQMS systems preferred.
- Basic understanding of validated production equipment is a plus.
Preferred Qualifications- Experience working in a medical device or other highly regulated manufacturing environment.
- Experience serving as a calibration lead, owner, or subject matter expert.
- Familiarity with eQMS systems and electronic documentation management.
- Experience supporting audits and maintaining audit-ready calibration records.
- Experience reviewing manufacturing documentation and Device History Records.
Skills- Strong organizational and documentation skills.
- Ability to review technical and manufacturing records for completeness and accuracy.
- Strong attention to detail and regulatory compliance requirements.
- Effective communication and cross-functional collaboration skills.
- Ability to manage multiple priorities and coordinate activities across departments and vendors.
- Ability to identify, escalate, and help resolve quality compliance issues.
- Strong problem-solving and analytical skills.
- Ability to work independently while supporting cross-functional teams.
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