Supplier Quality Engineering

Spectrum Plastics Group•Sandy, UT

78d•Onsite

About The Position

Spectrum Plastics Group (SPG) is a global supplier of engineered medical components and value-added solutions for the medical device and contract manufacturing industries. With a footprint that includes 20 manufacturing sites around the world, SPG provides precision extruded plastic solutions, injection molded components, balloons, and complex catheter assemblies to manufacturers and premier medical device brands, primarily in the medical device and life science market segments. Primary Objective: Supplier Quality Engineer ensures that the products produced by suppliers meet the quality standards and specifications of Spectrum. Will provide support to Spectrum and its customers through leadership in materials documentation for certifications (such as MDR, REACH, RoHS, Conflict minerals, Cal Prop 65, etc.), regulatory compliance, and risk management.

Requirements

Proven work experience as a Supplier Quality Engineer or relevant role in quality control.
Bachelor’s degree in engineering, Quality, or relevant field.
Experience with quality inspection, auditing, and testing methods.
Strong knowledge of quality control standards and testing methodologies.
Working knowledge of the manufacturing process.
Experience with quality systems regulations and standards (ISO 13485, ISO 9001, FDA 21 CFR 820).
Proficiency in MS Office, IQMS and familiarity with quality management systems.
Knowledge of applicable material compliance regulations and standards, such as REACH regulation, RoHS, Cal Prop.65, Conflicts Minerals, etc.
Strong analytical and problem-solving skills.
Good communication and negotiation skills.
Ability to travel for supplier visits.
Demonstrated ability to prioritize tasks and objectives
Demonstrated ability to identify and drive continuous improvements efforts
Strong communication/presentation skills, tailored to audience [oral, written, and/or presentation] including listening

Responsibilities

Evaluate and select suppliers based on their ability to meet product and schedule requirements.
Develop and implement supplier quality evaluation and control systems.
Conduct supplier audits to drive process standardization, waste elimination, and continuous improvement.
Monitor, communicate and improve key supply chain KPIs, including Supplier On Time Delivery, Defects Per Million Opportunities (DPMO) and Cost of Poor Quality (COPQ).
Work with internal and external stakeholders to resolve supplier quality issues.
Collaborate with supplier representatives on quality problems, ensure corrective actions are implemented and contribute to supplier quality improvement programs.
Manage and maintain supplier performance metrics, assessment, and certification programs
Train suppliers to execute specific quality system processes.
Manage supplier corrective action reports, NCRs and MRB activities.
Coordinate with engineering and procurement teams to ensure supplier compliance with contractual requirements.
Maintain compliance statuses of Spectrum business materials with existing, new or amended regulations.
Review of existing documents (procedures, work instructions, etc.) for accuracy, robustness, and compliance.
Performs other related duties as assigned by management.