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Manager, Quality Assurance in Thousand Oaks, California at Implant Direct

Date Posted: 12/5/2018

Job Snapshot

Job Description

Job ID: IMP000693

About Us

Implant Direct is one of the fastest growing major dental implant companies in the world today. We’re one of the many operating companies within Danaher Corporation’s dynamic portfolio of dental companies.  

Implant Direct operates a state of the art manufacturing facility in Thousand Oaks, California. We manufacture and distribute a broad range of value priced surgical, prosthetic and regenerative solutions to dental professionals in the US, Canada, and around the globe. We design and develop products which make high quality implants more accessible to patients around the world. We educate dentists on how to place implants and improve their patient care.

If you are interested in working in a lean, fast moving, entrepreneurial environment where you can learn, grow and make a difference, join us at Implant Direct. 


Description

JOB SUMMARY:
The Manager, Quality Assurance will lead the quality assurance, quality engineering, calibration, and QA Programming functions for Implant Direct. They will be responsible for driving performance with respect to product and process quality. This role will also be responsible for leading all efforts required to achieve and maintain compliance with all applicable worldwide standards, directives, and regulations, including but not limited to the US FDA, EU, Canada, Japan, Brazil, China, Australia, and others. The Manager of QA will establish, measure, and report performance against metrics, including DR (Nonconforming materials), FPY (First Pass Yield), etc., as applicable.

MAJOR RESPONSIBILITIES: 
  • Ensure organizational effectiveness in all areas of responsibility
  • Ensure the adequacy of qualified resources within all areas of responsibility
  • Ensure readiness for and participate as Subject Matter Expert and functional leader during audits and inspections from regulators, notified bodies, other 3rd parties, and internal compliance audits. 
  • Ensure all corrective/preventive actions, as assigned, or as assigned to team members are managed to completion and effectively implemented.
  • Provide leadership and direct the activities of the Quality Assurance organization 
  • Work in conjunction with Quality Systems to ensure timely performance of Health Hazard Evaluations, execution of recalls, and on-time reporting to applicable regulatory bodies of adverse events and field corrective actions in accordance with established timelines.
  • Develop key performance objectives and provide the necessary leadership and sound guidance to drive and improve performance of individual contributors, while continuing to improve the overall performance of the team. 
  • Collect & analyze data efficiently in order to support efforts to drive quality improvement, warranty cost reduction, new product launches, etc.  Partner with functional leaders (Operations, Engineering, Purchasing, etc.) to optimize relevant processes that ensure compliance and enhanced product quality
  • Build and maintain working knowledge of company product offerings 
  • Partner with and advise all functions and management on quality control and quality assurance related performance and requirements 
  • 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 through the implementation of industry standard and Danaher tools, such as FMEA’s, PFMEAs, Kaizen, Design for Reliability, root cause analysis, DOE, etc.
  • Collaborate with engineering or other functional groups in development, evaluation and documentation requirements for new product development and changes to existing products.
  • Lead quality and continuous improvement efforts across the business by utilizing trend data and the CAPA process and other appropriate mechanisms
  • Work collaboratively with other functions to assure the effectiveness of supplier improvement programs
  • Ensure the growth of the DBS (Danaher Business System) Culture within Quality Assurance; lead the implementation of DBS within QA
  • Performs other duties and tasks as assigned 

Job Requirements



Qualifications

REQUIREMENTS:
  • Bachelors of Science in Engineering or related field
  • 5+ years of relevant experience in Quality Assurance 
  • 3+ years of experience within the Medical Device industry or similar industry
  • 3+ years of experience of comprehensive Quality Management System and compliance responsibility / business processes
  • 3+ years of expertise in FDA QSR, ISO 13485, CMDCAS, and other applicable regulations: 
  • Knowledge of cleanroom and terminal sterilization processes and requirements
  • Experience related to the establishment and maintenance of design controls, and production/process controls
  • Proficient in the use of a computer, MSOffice suite knowledge/experience required 
  • Past experience performing the duties of Management Representative 

PREFERRED SKILLS/EXPERIENCE:
  • Masters degree
  • Regulatory Affairs Certification (RAC)
  • Past experience in leading continuous improvement efforts, related to process, product and/or quality systems
  • Experience with lean manufacturing and six sigma 
  • Black belt certification 
  • Completion of a ISO 13485 Lead Auditor Certification training
  • Experience related to the regulation of Class II and/or III medical devices
  • Demonstrable success leading complex organizations to high levels of compliance and performance
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.

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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.