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Life Sciences Quality Assurance Engineer 2 9/17/2017

JSR Micro, Inc. Sunnyvale, CA

Company
JSR Micro, Inc.
Job Classification
Full Time
Company Ref #
374342
Location
Sunnyvale, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular
AJE Ref #
579548867

JOB DESCRIPTION

APPLY
DUTIES AND RESPONSIBILITIES

Review, setting and updating of internal specs - internal teams, global subsidiaries and partners

Customer related quality questionnaires - developing templates reflective of our global business

Create internal documents and procedures to meet JSR quality standards and customer requirements

Operations - product release - Release of products entering Sunnyvale - gatekeeper of product release process - Handle quality related questions and issues

Advise quality requirements and compliance to meet customer requirements

Support product development efforts as a quality representative through product launch

review of Regulatory Support File

review of product manufacturing and raw material supplier

Conduct third party audits

Lead and develop harmonization plan for unified global QMS of current and future partners

Develops and implements processes, procedures, forms, metrics and tools for quality systems.

Reviews and revises/approves quality and validation documents.

Experience in change control, non-conformance investigations, new material and batch release, quality systems auditing and validation review.

Conducts training for Life Sciences, Bioprocess and IVD teams in quality systems processes to ensure adherence


KEY COMPETENCIES

Communication & Interpersonal Skills

Job Knowledge

Self-Management & Organizational Skills

Collaboration & Teamwork

Problem Solving

Project Management & Planning

Continuous Quality and Process Improvement

Creative & Innovative with a Customer Focus