About the role

Quality Engineer leading supplier quality management and process improvement in medical device production. Monitor supplier quality, manage risks, and ensure compliance with standards.

Responsibilities

Support Quality Systems including change control, supplier non-conformances, ASL management, Quality Agreements and department procedures and system, as assigned.
Perform and Support supplier/ EM quality evaluations and/or audits, development of quality agreements, and other quality related activities impacting supplier.
Lead activities associated with resolving supplier quality issues. This includes working with suppliers and internal partners to perform root cause analysis/failure investigations, identifying and implementing corrective actions, and monitoring for effectiveness.
Lead activities associated with supplier risk management. This includes working with suppliers to identify areas of high risk within their processes; establishing, monitoring and implementing supplier risk mitigation plans; participating in supplier risk management projects; and ensuring management awareness of risks, gaining support for mitigation efforts and tracking progress.
Lead activities associated with supplier process improvement. This includes working with suppliers to identify sources of variation within their processes; implementing process controls to improve process capability; and driving implementation of best practices.

Bachelor's Degree is required; Master’s Degree is preferred
Generally requires 4 – 6 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
Excellent communication, teamwork, and problem-solving skills are required
Expertise in all aspects of quality event investigations such as root cause analysis followed by comprehensive corrective action suggestions
Experience with machining, injection molding, metal processing such as passivation, anodizing and heat treating, and/or electronics assembly are preferred
FDA CFR and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge preferred.
Auditing background is a plus
Six Sigma, Lean, American Society for Quality (ASQ) certification and professional licenses are preferred
Strong statistical analysis skills are preferred
Fluency in English is required

Subject 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year