Supplier Quality Engineer
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Supplier Quality Engineer for a 9 month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
GENERAL SUMMARY: Manage all aspects of tier one and sub-tier supplier quality activities for assigned suppliers/ commodities; drive quality and process improvement at assigned suppliers/commodities. Assess, monitor, and ensure the continued adequacy and effectiveness of the quality system for the assigned supplier base. Support supplier selection, supplier process validation/controls, general supplier development. Review and approve inspection sampling plans for selection parts.
Ensure the proper validation of supplier processes and test methods and the product/process change management process.
Manage first article inspection process along with measurement system analysis (MSA), component qualification, and process validation including Physio-Control manufacturing process verification if required.
Approve supplier manufacturing/test/inspection plans and procedures; perform periodic supplier audits and risk assessments.
Work closely with tier one suppliers to sustain and improve component quality.
Ensure accurate and complete preparation of supplier quality engineering documents as required, including but not limited to component qualification/process validation plans, supplier audits/approvals, incoming inspection planning, and other miscellaneous quality documentation and records.
Support new supplier development and commodity team strategies.
Participate in design reviews with the development teams.
Maintain supplier key performance indicators (KPIs) and drive continuous improvement; support any score carding activities.
Ensure suppliers have work in process (WIP) and traceability tracking at supplier sites.
Correlate and standardize test and inspection processes as required.
Drive failure analysis and corrective actions/supplier corrective action requests (SCAR) within assigned suppliers/commodities.
Support MRB/non-conforming material processes as well as approved vendor list (AVL) sign off procedures.
Maintain 100% compliance to Physio-Control processes and procedures.
May participate in definition of critical-to-quality/process/function parameters for critical components/sub-systems.
Generally supports less complex commodity suppliers; may support senior supplier quality engineering staff with more complex commodity suppliers.
Other related duties as assigned.
Bachelor' s degree in an engineering or technical science, or equivalent combination of education and directly relevant experience
2 years directly relevant experience, with prior experience in a FDA/cGMP or regulated environment
4+ years of directly relevant experience
Prior experience working with electrical, mechanical, and/or electro-mechanical commodities
Demonstrated understanding of statistical control and quality management principles
Excellent verbal and written communication skills
Ability to work with minor guidance and under pressure
General statistical quality tools knowledge with process capability; demonstrated ability to apply six sigma and statistical quality control methodologies
Knowledge of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc.
ISO Auditor trained or experience with supplier auditing
Ability to drive and deliver innovative, effective and timely solutions
Significant use of standard office equipment, including computer keyboard, monitor, and mouse
Domestic and international travel (20-40%)
Ability to lift up to 35 pounds