Quality Systems Auditor

Location
United States
Posted
Mar 28, 2021
Ref
452389
Required Education
Other
Position Type
Full time
Are you looking for a unique opportunity with a small, innovative, and close-knit team that values integrity, mutual respect, and a work-life balance? Do you enjoy a challenging and changing environment, and like to roll up your sleeves to get things done?

Cannon Quality Group is looking for an experienced and highly organized Team Member to work in a key role focused on performing quality system audits for clients. Based on our Alamo, CA headquarters, this role also ensures the ongoing success of the entire Team in implementing smarter Quality Management systems for our client companies.

When applying, please provide a cover letter and resume. Failure to follow directions will immediately eliminate you from consideration (it's our most simple of screens)!

***** All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

PURPOSE OF JOB: Primarily responsible for conducting internal quality system audits for long-term CQG clients (maybe on-site at Client), full system QSR, and or ISO type audits for contract clients, gap analysis, external standards review, and supplier audits.

MAJOR DUTIES AND RESPONSIBILITIES:
  • Manage & conduct audits to assure compliance and continual improvement
  • Maintain current knowledge of standards
  • Conduct audits independently and as part of a team:
    • Supplier audits - contract manufacturers (CMO's), contract sterilizers, custom part manufacturers
    • Internal audits - full or partial quality system audits for ongoing CQG clients and for contract clients
    • Clinical laboratory audits - audits of clinical testing facilities for design validation (GLP)
    • Mentor and train new auditors
  • Complete audit reports in a timely manner
  • Work with the internal quality support team to efficiently plan audits
  • Travel to Clients local and potential Domestic Travel to clients required
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, ISO Standards, and FDA regulations


EXPERIENCE REQUIREMENTS:
  • Five (5) or more years of quality experience in the medical device industry
  • Must have general understanding of US FDA Quality System Requirements (CFR 820), ISO/EN 13485, and MDD requirements (knowledge of Canada's (CMDCAS) requirements a plus)
  • Must have strong written, oral, interpersonal, group, and communication skills
  • Ability to travel worldwide (out of area travel approx. 20%)
  • Must be able to follow established policies and procedures, recommend changes in existing procedures, and comply with regulatory requirements
  • Ability to recognize problems, communicate with appropriate parties
  • Computer skills are needed, with experience using Microsoft Access, Word, Excel, and PowerPoint highly preferred
  • Experience with QuickBooks preferred


EDUCATION REQUIREMENTS: Bachelor's degree or equivalent experience; preferably in a science related field

QUALIFICATIONS
  • 5+ years of in-depth Quality System auditing in compliance with FDB, FDA, and ISO 13485
  • Must have experience hosting Notified Body Audits
  • Certified Quality Auditor Training as Lead Auditor Strongly Preferred
  • Quick to learn
  • Excellent interpersonal and communication skills
  • Ability to work independently and collaboratively
  • Ability to prioritize and manage to critical project timelines in a fast-paced environment
  • Must be organized, high attention to detail, and be able to put ideas into a tangible form


Our Company Culture: Are you a Fit?

We're good people - who like to work with good people. We take our jobs seriously, but also like to have fun. We genuinely care about others and helping our clients solve their problems. You can get a sense of our company culture by understanding our VITAL core values, which include: Versatility, Integrity, Teamwork, Accountability and Life Balance. You can expect nothing less from us and we'll accept nothing less from you!

About Cannon Quality Group

Since 2007, Cannon Quality Group, LLC has been providing Quality System solutions to start-up medical device companies that are engineer focused and compliant. Our primary focus at Cannon Quality Group, LLC, is to aid in getting new safe medical devices into the clinic fast so we can help improve the lives of patients. We offer Quality Management Solutions that make sense for the stage and goals of each business through consulting, document control, supplier support, inspection/testing/validation, and other Quality System requirements and services. For more: http://www.cannonqualitygroup.com/job-opportunities/.