Implement SQ strategy and follow Supplier Quality standards
Manage Supplier related Non-Conformities (NC and SCAR's) and Corrective and Preventive Actions (internal CAPA's)
Oversee supplier change requests (SCR) with Procurement
Support Process Validations at suppliers
Support QE with supplier product PVE's (First Article Inspection, Control Plans, Critical to Quality, Capability studies)
Contribute to product investigations related to SCAR internal CAPA
Support supplier preparation for inspections by authorities / third parties
Support Procurement executing supplier transfer projects
Support for Quality Agreement and Change Agreements, supplier assessments and supplier audit process
Prepare regular report and supplier quality metrics
Lead or participate in Quality projects: Legacy review, remediation, integration
Implementation of improved/new standards for supplier quality
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Requirements

Bachelor's Degree is required
Generally, requires 5-7 years of work experience in a GMP and/or ISO regulated industry
Experience in the medical device / pharmaceutical industry is preferred
Engineering or science field of study is preferred
Strong communication, teamwork, and problem-solving skills are required
Experience in machining, injection molding and/or electronics assembly is preferred
FDA CFR Part 820 and/or ISO 13485 knowledge is preferred
Six Sigma, Lean, American Society for Quality (ASQ) certification and professional licenses are preferred
Fluency in English is a must

Benefits

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Supplier Quality standardsNon-Conformities managementCorrective and Preventive ActionsProcess ValidationsFirst Article InspectionControl PlansCapability studiesQuality metrics reportingSupplier assessmentsSupplier audit process

Soft Skills

communicationteamworkproblem-solvingleadership

Certifications

American Society for Quality (ASQ)