Senior Supplier Quality Engineer

Role Overview

• 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.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

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

Tech Stack

• Assembly

Benefits

• ubject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year