Quality Engineer II AccessClosure

SUMMARY: Partner with internal departments to efficiently deliver safe and effective medical device designs and processes for manufacturing in line with AccessClosures policies and procedures. Provide quality assurance support to all functions. This includes supporting project teams on new and existing process and product development activities to ensure that processes and products are designed and developed in accordance with customer, corporate and regulatory guidelines.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
Actively participates in all design control and process change activities, to include:
o Design reviews to ensure that the design meets the intended customer needs and that all requirements are documented;
o Technical development of test plans;
o Risk management activities
o Coordinate and execute validation activities for:
o biocompatibility testing,
o stability (shelf life) studies,
o sterilization validation,
o test method validation,
o Design Verification Testing
o Identify testing and analysis required for the finished device to ensure device conformance to product specifications;
o Provide support for process validation and design transfer activities
Act as supplier liaison on technical problems, as required
Create, review and approve engineering documentation (protocols, reports, specifications, manufacturing instructions)
Perform root cause investigations to support resolution of production issues
Perform internal audits
Provide technical support to the quality inspection group, as required
Perform basic statistical analyses, as required
Provide support to Operations, as required
Participate in third party (Notified Body, FDA) audits as required
Other duties may be assigned on an individual basis

EDUCATION/EXPERIENCE:
Bachelor of Science degree in an engineering discipline and a minimum of 3 years previous, related work experience in the medical device or pharmaceutical industry
Ability to perform multiple tasks concurrently with accuracy
Must have demonstrated hands-on experience in:
o design verification and validation,
o hazard/risk analysis, design/process FMEA,
o process validation,
o FDA Good Manufacturing Practices (GMP).
o ISO13485, 21 CFR Part 820
Clear and effective communication skills
o Proficiency in MS Word, Excel and Power Point required
o High attention to detail and accuracy is required

WORK ENVIRONMENT:

Work includes potential exposure to human bloodborne pathogens or other potentially infectious materials.
Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
Work includes potential exposure to chemicals.

SUPERVISORY RESPONSIBILITIES:

No direct supervisory responsibilities.

Location:	Mountain View, CA United States