Quality Control Engineer II

Exciting Senior Quality Engineer - Metrology opportunity with an established medical device manufacturing company.

Contract Duration: 12 Months
Required Skills & Experience
5+ years of Quality Engineering experience supporting metrology and calibration systems
2+ years of experience leading or supporting calibration/metrology remediation efforts in a regulated manufacturing environment
Strong knowledge of ISO 13485, 21 CFR Part 820/QMSR, ISO 17025, Gage R&R, and MSA methodologies
Expertise in dimensional metrology, calibration principles, measurement uncertainty, tolerance analysis, traceability, and guard banding
Experience conducting OOT/OOC investigations, impact assessments, CAPAs, risk assessments, and deviation management
Ability to analyze calibration data and equipment performance using risk-based decision-making methodologies
Experience supporting internal, customer, and regulatory audits
Proficiency with Minitab or similar statistical analysis tools

Desired Skills & Experience
Metrology experience in the medical device industry
Experience with CMMs, vision systems, automated assembly equipment, force/torque measurement, environmental monitoring, and packaging equipment
Familiarity with cleanroom environments and standards including ISO 9001, ISO 10012, and ANSI/NCSL Z540
Working knowledge of ProCal V5 and Siemens Teamcenter
Strong project management and cross-functional leadership skills
What You Will Be Doing
Tech Breakdown
Metrology / Calibration Program Remediation - 70%
Risk Assessment, Compliance, and Quality Systems Activities - 30%
Daily Responsibilities
Lead calibration program assessments and remediation initiatives
Perform gap analyses and develop sustainable remediation plans
Conduct OOT/OOC investigations and product impact assessments
Drive CAPA activities and quality system improvements
Author and revise calibration procedures, deviations, risk assessments, and impact assessments
Evaluate measurement systems, calibration intervals, traceability, and fitness-for-use decisions
Partner with Engineering, Manufacturing, Validation, Laboratory Operations, and Quality teams
Support internal, customer, and regulatory audits
Train stakeholders and implement long-term metrology process improvements