Quality Assurance Engineer

Alembic, LLC. - Mountain View, CA (30+ days ago)


Quality Assurance Engineer Job Duties:

· Implement sound and relevant quality engineering and compliance methods and principles to support development, qualification, and on-going manufacturing of products to meet or exceed internal and customer requirements.

· Apply systemic problem-solving methodologies in identifying, communicating and resolving quality issues.

· Plans and conducts projects and assignments with technical responsibility or strategic input.

· Lead or support the application of quality engineering/compliance of projects of various functions and levels.

· Ensure continuous improvement of quality system and product quality through the implementation and maintenance of quality metrics and NCR/ CAPAs.

· Develop and maintain risk assessment and mitigation plans through Control Plans, FMEAs and other risk assessment tools.

· Provide expertise in cleanroom, sterilization, biocompatibility, packaging, shelf life validation and post-sterile product release. Lead failure investigations related to the above-mentioned areas.

· 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 (traveling required).

· Operate more independently and occasionally writes training material and conducts training sessions on quality activities.

· Maintain an updated knowledge in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk management and Statistical Techniques.

· Responsible for ensuring compliance with all Federal, State, local and company regulations, policies and procedures.

Skills/Requirements:

Education & Experience :

· B.S. degree in engineering or in a scientific discipline is required.

· 2-5 years of quality function experience in medical device industry.

· 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 audit

· Ability to work in an office environment, CER and travel to supplier sites as required.

Job Type: Full-time

Experience:

  • Medical Devices: 2 years (Required)
  • Quality Assurance: 2 years (Required)