Quality Engineer II

Bachelor’s Degree
A minimum of 2 years confirmed experience or a combination of equivalent education and shown experience.
Moderate knowledge of applicable regulatory, Corporate and/or Unit requirements.
Training in statistics.
Class II / III medical device experience (preferred).
Knowledge of design control principles (preferred).
Ability to provide support to internal / external audits.

Moderate level application of technical principles, theories, concepts, techniques and quality sciences / tools.
Develops solutions to routine problems of moderate scope.
Follows company procedures and makes basic procedural updates.
Developing working knowledge of applicable regulatory, Corporate and/or Unit requirements.
Communicates across functions / departments for assigned areas of responsibility.
Is an extended team member representing Quality on new product development projects and a team member for sustaining engineering projects.
Provides audit support (preparation, closure, etc. activities).
May perform other duties as required.
Design Control: Design Input, Design Output, Design Verification plans, protocols, and reports, Design Reviews, Design Validation, Design History File support.
Change Control: Assessment of Change Request (ACR) Responses, Risk Management, Process Validations, Identification of CTQ’s, Unit Quality Independent Reviewer During Design Reviews, Handling of deviations and non-conformances, Test method validations, Supplier qualification, Software validations, Post Market Surveillance, Situation Analysis, CAPA – Root cause investigation and implementation of corrective / preventive actions, Accurate Use of Statistics (Sampling Plans), Advise on Regulations, Liaise with Manufacturing Plants, Provide functional support to multi-functional teams, Internal and external audits.