Quality Engineer I at Spectrum Plastics Group

Tucson, Arizona, United States -

Full Time

Start Date

Immediate

Expiry Date

31 Jan, 26

Salary

0.0

Posted On

02 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, Electronic Quality Management System, Inspection Methods, Continuous Improvement, Document Control, Corrective Action, Preventive Action, Supplier Quality, Calibration, Auditing, Lean Six Sigma, GD&T, ISO Standards, Technical Writing, Interpersonal Skills, Organizational Skills

Industry

Medical Equipment Manufacturing

Description

Job Details Job Location: Xeridiem - Tucson - Tucson, AZ Position Type: Full Time Salary Range: Undisclosed Job Shift: 1st Shift Description JOB PURPOSE: To ensure on-going product quality through implementation of quality system processes and procedures. ESSENTIAL DUTIES: Ensure that the organization’s Quality management System conforms to customer, internal, ISO 13485:2016 and regulatory/legal requirements. Be the technical expert in the Electronic Quality Management System and modules that control relevant functions. Oversee process and product inspections that include deciding and implementing inspection methods, sampling plan and inspection equipment. Assist in preparing for quality meetings and management review meetings to report to top management technical data regarding the performance and effectiveness of the quality management system. Work with engineering and quality manager and lead quality/continuous improvement projects. Work closely with the customer and develop quality assurance plans for new customers and improve process efficiency for existing customers. Provide support in entering of RMAs, CAPA, monitoring of DCRs and Deviations, and PPM tracking. Assist in document control functions by creating new operating procedures, work instructions, forms etc. Responsible for supporting Engineering and Manufacturing to resolve technical issues and implement corrective and preventive action (CAPA) Maintain KPI’s as required by Quality Management System Leading supplier / internal process improvement projects to increase the supplier/internal process capability of consistently meeting ISO and regulatory requirements. Leading projects including process analysis, value stream mapping, process capability and throughput analysis, DOE, 6‐Sigma, 5S and Kaizen events. Act as the Supplier Quality Representative and conduct all Supplier Quality Reviews. Programming CMMs and other measurement gages to customer drawings Assist maintenance department with external and internal calibration of critical measuring equipment. Manage, coordinate, and assist teams for internal and external validation/verification of processes. Assist in audits which includes ISO 9001:2015, 13485:2016 Internal, External, supplier and Customer audits. Collaborate with external interested parties to improve Quality management system. Implements improvements using the CAPA system. Prepares written protocols and reports. Responsible for managing and scheduling the routine sterilization validations. Writing, reviewing, approving sterilization technical protocols and report. Assists with maintaining established departmental policies and procedures, objectives, and quality improvement, safety, and environmental standards. Upholds SPG and Dupont vision and core values. Performs other duties as required. Qualifications QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities) Required: Bachelors’ degree or higher in Engineering/Science in Engineering Management/Mechanical/Manufacturing/Industrial Engineering or related field with 2+ years’ experience Has knowledge of commonly used concepts, practices, and procedures within the field, including regulatory affairs. Ability to problem solve, identify errors and deficiencies, and perform research with general guidance. Ability to apply knowledge to their job function using pre-established guidelines and instructions Accuracy, attention to detail, and thoroughness Proficient computer skills Proficient communications skills Ability to comprehend and comply with company safety and quality standards Ability to follow oral and written instructions Responsible for understanding and complying with all SPG and Dupont safety policies and procedures. Preferred: Previous experience in Quality Assurance Rudimentary knowledge of statistics Medical device experience Lean Six sigma Green Belt certification or higher desired. Knowledge of GD&T and ISO 13495:2016 standards Experience in using precision measurement tools like Vision systems, optical microscopes etc. Experience working in ISO Class 8 cleanroom environment. Knowledgeable of Control Plans, DOE, FMEA, SPC, and other lean six sigma tools Excellent verbal, technical writing, interpersonal and organizational skills required. WORKING CONDITIONS: Works under immediate supervision. Primary job functions do not typically require exercising independent judgment. This position requires about 50% of time spent sitting and working on computer. The other 50% of time would be spent moving around on the Production floor where protective clothing is necessary.

Responsibilities

The Quality Engineer I is responsible for ensuring ongoing product quality through the implementation of quality system processes and procedures. This includes overseeing inspections, supporting engineering and manufacturing, and leading quality improvement projects.