Quality System Engineer

Quality Systems Engineer

Description

Purpose and role of job:

Assists in the development, implementation, and effectiveness of Quality Management System (QMS). Support integration of QMS with software platforms to share and manage content to derive knowledge and metrics in a collaborative work environment. Where appropriate, the content design drives corrective actions to deliver on quality objectives/goals

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Principal Accountabilities/ Responsibilities:

· Responsible for continuous improvement of QMS through leadership of Self Improvement Planning (SIP):

o Outlines Internal Audit Plans against industry quality standards and best practices.

o Creates and manages Corrective Action / Preventive Action (CAPA) Plan with metrics to monitor progress against objectives.

o Performs periodic reviews of CAPAs and Internal Audits to sustain efforts.

o Assists with planning and execution of External Audits and related CAPAs as needed.

o Calculates, updates, and monitors quality metrics.

o Works with cross-functional departments as needed to support system update / implementation consistent with meeting quality goals.

o Provides training to Team Members as required for implementing quality initiatives.

· Primary Vision System Leader for troubleshooting issues and providing guidance to team responsible for system reliability.

o Sets up new recipes and classifiers for new products.

o Optimizes recipes and classifiers as needed.

o Checks on inspection systems daily

o Sets up safety factors.

o Calibrates and validates Vision System Cameras.

o Addresses MES issues.

o Coordinates with OEM as necessary.

· Quality Engineer Responsibility

o Acts as primary QA contact for assigned customers.

o Establishes effective working relationships with assigned customers.

o Investigates, determines root cause, and implements effective CAPAs for customer complaints.

o Works collaboratively with cross-functional departments to define customer needs and meet expectations.

o Receives, reviews, and initiates approval process for customer specifications.

o Initiates and participates in Technical Standard Change Request (TSCR) system as needed.

Education and experience requirements:

· BS Degree in an Engineering, Technology, Mathematics, Business, or Science discipline.

· 5+ years in technical role in manufacturing environment desirable.

· Knowledgeable in usage and set-up of web-based applications and software packages.

· Experience in Internal and External Auditing against quality standards (ISO, EDANA, and/or GMP).

· Strong written and verbal communication skills

· Demonstrated technical, business, and leadership skills.

· Knowledge of quality systems (ISO, EDANA, and/or GMP).

· Skilled in statistics, problem solving, and procedure implementation.

· Exceptional competence and professionalism in interactions with executive management, customers, and vendors.