Senior Quality Engineer AccessClosure

SUMMARY/RESPONSIBILITIES:

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 in depth quality engineering support to the project teams to ensure that products and processes are designed and developed in accordance with customer, corporate and regulatory guidelines.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

Work closely with the product development group to ensure marketing/product specifications are aligned and integrated into the Design Control Process from Design Input creation through product release.
Coordinate risk management activities (FMEA, Hazard Analysis, etc). Additional responsibilities will include execution of biocompatibility, shelf life, sterilization and test method validations.
Actively participate in design reviews, design verification/validations, product/marketing specifications and other necessary design related elements to ensure that the design meets the intended customer needs and that all requirements are documented.
Ensure and verify that suppliers understand AccessClosures requirements for design deliverables and ensure that test plans are appropriate.
Review and approve technical instructions (IFU's) for adequacy to ensure customer satisfaction and provide hands-on team support to ensure an effective product acceptance.
Provide technical, root cause analysis and statistical support to resolve production issues.
Provide validation and verification plans for design and process changes.
Provide continued quality system support by improving processes and systems and by updating and creating SOPs.
Perform internal and supplier audits.
Support non-conforming material resolution and complaint investigations, as needed.
May provide reliability test support.
May manage key quality system programs such as Non-conforming materials, supplier quality, CAPA, dose audits, environmental monitoring, CER re-certification, reliability testing and shelf life establishment.
Participates in third party (Notified Body, FDA) audits as required.
Other duties may be assigned on an individual basis:

EDUCATION/EXPERIENCE:

Bachelors Degree in engineering discipline and a minimum of 5 years related work experience with at least 3 years experience in the medical device industry.
Demonstrated extensive hands-on experience in Medical Device Design Controls, FMEA, Hazard Analysis, DOE, gauge R&R, SPC, GMP, ISO13485, 21 CFR Part 820, design verification, process validation, design validation, auditing and reliability testing.
Possesses excellent communication skills with all levels of management and technical organization.
Competence in evaluating new test methods, processes and materials to determine effect on project deliverables.
Demonstrated effective project team skills while working in an environment, which requires definite structure for design controls and product
Demonstrated proficiency in statistical application preferred.

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:

May supervise quality technicians.

Location:	645 Clyde Avenue Mountain View, CA 94043 United States