Quality Assurance Specialist

Cepheid Orange , CA 92856

Posted 2 weeks ago

Major Responsibilities:

  • Support CAPA, NCR and complaints activities.

  • Participate in process improvement projects.

  • Updates QA master procedures and forms as needed to comply with external regulatory requirements.

  • Support the QMS harmonization project across Dental Co.

  • Support internal and external audits, including all required correspondence and required corrective/preventive actions

  • Support the KaVo Kerr QA organization for centralized systems: CAPA, Internal and External Audits, Management Controls, Training, Software Compliance, Design Control, Supplier Management, Complaints Handling, Post-Market Surveillance.

  • Provide sound guidance to drive and improve performance of individual contributors.

  • Work with project teams and colleagues involved with the development of new products on quality requirements, assist engineering or other functional groups in prototype development, evaluation and documentation

  • Proactively improve quality and compliance through the implementation of industry standard and DHR tools, including FMEA's, Kaizen, etc.

  • Support post-market surveillance activities.

  • Performs other duties as assigned.

Minimum Requirements:

  • Bachelor's Degree; a combination of education and 5 years of experience working in medical or dental device industries may be considered in lieu of a degree.
  • 2-5 years' experience working in a regulated industry; preference will be give to candidates who have experience working in medical/dental device industries.

Preferred Requirements:

  • Proven experience in implementing quality systems in an FDA/ISO regulated environment

  • Ability to read and interpret documents such as contracts, operating and maintenance instructions, and procedure manuals.

  • Past experience in leading continuous improvement efforts, in both quality, systems and products

  • Ability to read and comprehend instructions, short correspondence and memos.

  • Ability to write complex correspondence and reports.

  • Ability to respond to inquiries or complaints from staff members, other department members and contacts in the business community.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

#LI-LT1

IND-KAV1


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