QA Engineer in Yorba Linda, California at Nobel Biocare

Date Posted: 6/14/2018

Job Snapshot

Job Description

Job ID: NOB002274

About Us

Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.

Description

The QA Engineer works with associates on site to ensure compliance is followed in accordance with The FDA’s QSR Regulations, ISO 13485, MDR, and MDSAP Requirements as appropriate.  Maintain the Corrective and Preventive Action (CAPA) process.  Coordinate and work with different functional departments to ensure Procedures and SOP’s are properly documented and reflect the day to day operations.  

Responsibilities & Duties:
  • Support the Quality System Compliance function to ensure continued compliance in accordance with the FDA’s QSR Regulations, ISO 13485, MDR, and MDSAP Requirements as appropriate.  
  • Coordinate and maintain the CAPA process. 
  • Work with associates from different functional departments to address any corrective and preventive actions identified.  
  • Provide trending for site Management Review.  Lead or assist with the Internal Audit program.  Provide support during site inspection/audit.  
  • Provide Compliance training for the site.  Interface with Engineering, Operations, and Quality personnel to ensure compliance to the internal requirements and applicable Regulations and Standards. 

Job Requirements



Qualifications

REQUIREMENTS:
  • Bachelor's degree from a four-year college or university 
  • Minimum of 4 + years Quality Assurance Engineering experience in medical/Pharma regulated manufacturing environment is required
PREFERRED SKILLS/EXPERIENCE:
  • Experience with QA processes involving machining of small components and automation is desirable.
  • Excellent communication skills - verbal and written.
  • Systematic problem solving skills
  • Knowledge of analysis tools- Minitab etc 
  • Ability to work independently as well as be a collaborative member to a team.
  • Knowledge and prior use of SAP, or equivalent system.
  • Efficient in Microsoft Office and other computer skills.

Nobel Biocare is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

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Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and industrial solutions. Our globally diverse team of 59,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #144 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.