Quality Engineer AngioScore
THIS JOB HAS EXPIRED AngioScore:
AngioScore?s Scoring Balloon Catheter significantly alters the landscape for treating both peripheral arterial disease and coronary artery disease.
Location and Reporting Relationship:
AngioScore is based in Fremont, California. The position reports to Director of Quality Engineering and Quality Management Systems
Quality Engineering / Quality Management Systems
Provide quality engineering support for operations (manufacturing, supplier quality) in addition to developing and maintaining quality systems.
MAJOR DUTIES AND RESPONSIBILITIES:
Facilitate the launching of new or improved products/processes, and the transfer of technology from development to commercialization from a Quality and manufacturing perspective. Work with the Manufacturing, Clinical, Regulatory, Sales and Marketing, and Research and Development functions to coordinate pilot production of new products.
Write and coordinate efforts for the development and implementation of new and updated Quality System procedures such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development and task force projects.
Conduct statistical analysis (F-test, t-test, ANOVA, normality tests, etc) and generate trend reports for projects on an as-needed basis.
Utilize Quality Engineering tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, conduct process and systems audits and to assist in specification development.
OTHER DUTIES AND RESPONSIBILITIES::
Coordinate the reporting, analysis, and resolution of material non-conformance incidences. Participate in Material Review Board meetings, as needed.
Develop quality assurance specifications, test methods, sampling plans and related written procedures.
Coordinate the identification, assignment, monitoring, and completion of product improvement projects in cross-functional teams.
Assist Regulatory Affairs Department in preparation of regulatory submissions and interface with the FDA or other regulatory agencies in case of on-site audits.
Conduct quality audits and develop subsequent preventive action programs.
Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Document Control, Clinical, Regulatory, and Research and Development functions.
Conduct returned product analysis investigations and DHR review. Perform trending on complaint rates and provide feedback to management team.
Manage Class I, II or III recall activities, including preparing recall binder and leading the reconciliation of recall inventory between product returned and ERP system. Conduct follow-ups with customers on an as-needed basis. Assist in preparation of 21 CFR 806 FDA report.
EDUCATION /EXPERIENCE REQUIREMENTS::
BS in Engineering (preferred), life sciences or other related field.
Minimum of 5 years of work experience in the medical device industry.
5-10 years overall QA experience
Experience with FDA requirements, knowledge of regulations such as GLP, GMP, ISO 13485 and other international regulatory requirements. Working knowledge of Japanese MHLW ministerial ordinance 169.
Proficiency with statistical software package (such as Minitab and JMP) and CAD software is preferred.
ASQ CQE (Certified Quality Engineer), CSSBB (Certified Six Sigma Black Belt) and/or Certified Auditor certification is preferred.
||5055 Brandin Court |
Fremont, CA 94538
THIS JOB HAS EXPIRED