Corporate Quality Systems Auditor

East Bay, CA | Direct Hire

Post Date: 09/27/2017 Job ID: 1003 Industry: Software/Hardware

Our Company s is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers

You may be just who we are looking for!

Our company is growing! We're looking for at Corporate Quality Systems Auditor to join our Fremont,CA team!

 

 

As a uniquely qualified candidate, you will:

  • Performs planned, internal audits locally and periodically across corporate organizations for compliance to applicable government and international regulations and company procedures

  • Assigns classifications and documents audit results in written audit reports.

  • Assigns actions or Corrective actions for deficiencies as needed and required.

  • Updates the training matrix

  • Can serve as lead auditor leading a technical experts and auditors-in-training.

  • Performs database administration for compliant Pro Software

  • Maintains files containing reports of audits and corrective action responses.

  • Escorts auditors representing government agencies and suppliers.

  • Reviews audit responses and assist with required training in response to audit findings and other GMP/QSR/ISO/MDD/CMDR related issues as needed.

  • Performs cross-site audits as requested by management.

  • Provides direction and guidance to auditors in training.

  • May collect compliance metrics and generates data for management reviews.

  • Maintains abreast of regulatory change through industry publications,seminars,participation in trade organization, and government meetings.

  • Responsible for following all company guidelines related to Health,Safety and Environmental practices and that all resources needed to do so are available and in good condition.

 

Education and Experience:  

  • Must have Lead Assessor Training. The Lead auditor/assessor qualifications include the completion of Lead Auditor/Assessor Training program conducted by BSI/ASQ or other similar external authority to any manufacturing management standard, including ISO 9000 and ISO 13485.

  • BS in a related field of study; and 5 or more years of related experience and/or training; or MS with 3 or more years; or equivalent combination of education and experience.

  • Experience in dealing with the Food & Drug Administration.

  • Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, supplier quality management principles and their applications and quality management tools and their applications.

 

Confluent Medical Technologies offers very competitive compensation and benefits and is proud to have a distinguished reputation across Silicon Valley and throughout the medical device industry around the world! We welcome eager and ambitious team players to apply. There’s no better time to join Confluent!

Qualified candidates will be contacted. No phone, fax or email inquiries from potential applicants, external recruiters or other interested parties, please.

We regret that we are unable to sponsor employment visas or consider individuals on a time-limited visa status for this position.

Transforming Concepts into Reality

Confluent Medical Technologies is an equal opportunity employer.


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