Principal Quality Engineer

Company: Alembic Llc
Location: Mountain View
Posted on: January 12, 2022

Job Description:

Responsibilities:
Includes the following and other duties may be assigned:Lead design assurance activities in support of new product development or system and product continuous improvement projects.Strong understanding and practical application of design and development standards such as IEC 60601, 62304, 62366 and ISO 13485.Working knowledge of risk management processes such as the Failure Modes & Effects Analysis (FMEA) and other risk management tools/techniques.Experience and working knowledge of FDA regulations/ISO standards for medical devices such as the ISO 13485/GMP.Maintain supplier quality program by working collaboratively with product and service suppliers.Activities include supplier performance evaluation, quality investigation, product testing, and performing occasional onsite audits/ visits (occasional traveling may be required).Lead or support the application of quality engineering/compliance of various functions and levels with technical responsibility or strategic input.Follow Alembic QMS system, policies, and SOPs to ensure that FDA, EU, and other applicable regulatory body required standards and regulations are met.Manage quality resources to meet the different needs of the organization.Develops, modifies, applies, and maintains quality standards and protocols.Lead complaint investigations.Document findings and provide reports and analysis
Skills/Requirements:
Education & Experience:B.S. degree in engineering or a scientific discipline is required.7+ years of medical device industry experience in engineering or Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering.CQE certification preferred.Abilities/Skills:Strong technical writing and communication skills.Independent, team player and lead by example.Ability to multitask and complete deliverables on time.Ability to lead, represent or participate during quality system audits.Ability to work in an office environment, CER, and travel as required.by Jobble

Keywords: Alembic Llc, Mountain View , Principal Quality Engineer, Engineering , Mountain View, California