Quality Engineer Ii

Description:

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Understand and support the design and development of new or improved

products in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs. Support Design Reviews, Technical Reviews, and Gate Reviews.

• Understand and support the execution of all Risk Management and Usability Engineering process activities, including design, process, and application FMEAs.
• Review for approval other Risk Management Documentation: Risk Management Plan/Report, Hazard Analysis, Benefit-Risk Analysis (BRA).
• Support external partners in the development of products, including review

and approval of development documentation such as product
requirements, schematics, verification, and validation strategy/execution.

• Coordinate and review development documentation created by external

partners.

• Develop Reliability models for predicting product performance over time

(where applicable).

• Support implementation of SPC programs with Manufacturing and Quality

Control as a part of Process Validation and Design Transfer.

• Knowledgeable of and applies statistical analysis to support data-driven

decision making.

• Work with project teams to develop DOEs and statistically sound tests for

appropriate support of results.

• Supports developing statistically based sampling plans for Design

Verification and Validation, Process Validation, or other studies as
deemed necessary.

• Participate in FDA inspections, ISO Certification and surveillance audits,

customer audits and internal audits as an NPD and/or
Sustaining/Remediation subject matter expert.

• Writing & coordinating efforts for the development and implementation of

new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs to support development and sustaining/remediation projects.

• Maintain all projects are in compliance with GMP, QSR, ISO or other

applicable requirements.

• Identify and implement opportunities for continuous improvement in the

quality system.

• Interact and coordinate activities with other departments, external

vendors, and customers.

• Perform other Quality Systems related duties as required.