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Quality Engineer in Thousand Oaks, California at Implant Direct

Date Posted: 3/15/2019

Job Snapshot

Job Description

Job ID: IMP000742

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 Quality Engineer is responsible for performing a wide range of Quality Engineering activities, with the purpose of supporting the Inspections and Production operations. The incumbent for this position will be reporting directly to the Quality Engineering Manager, and will complete various engineering support duties including, (but not limited to), process validations, equipment qualifications IQ/OQ/PQ, and Gage R&R studies. The Quality Engineer will play a crucial part in improving our compliance posture and product quality.


ESSENTIAL DUTIES:
  • Work closely with Operations and Inspections personnel to ensure that processes are capable of reliably producing product that consistently meets product specifications. 
  • Ensure that process and equipment improvements/upgrades are properly planned validated as required, and placed into production so that resulting product can be produced with the required quality and repeatability.
  • Perform engineering studies of Gages (R&R) to ensure they remain capable of making the necessary measurements and decisions, and that they are deployed in such a way that users are trained, the measurement uncertainty is known and accepted product resulting from these inspections meets specifications.
  • Provide leadership and direction for activities supporting complaint and CAPA investigations; ensure timely completion with all assigned activities.
  • Provide leadership and be accountable for support for CAPA’s, Nonconforming Materials processes, and quality systems related responsibilities. 
  • Lead/Participate in risk analysis and management.
  • Deploy and utilize Statistical Process Control (SPC) and or statistical techniques, as applicable.
  • Perform statistical sampling, as needed, to ensure product quality and process performance.

Job Requirements



Qualifications

REQUIREMENTS:
  • Bachelor of Science degree in Engineering or related Engineering field required; CQE Preferred. 
  • Minimum three (3) years of Quality Engineering experience, preferably in a Class II or III medical device environment required. 
  • Knowledge of design controls, US FDA QSR, ISO 13485, ISO 14971 and other applicable standards and regulations required.
  • Working knowledge of statistics and statistical packages (MiniTab) and design software required; Solid Works is desirable.
  • Ability to clearly communicate and write reports and business correspondence in English
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and other key members in the company while maintaining a high level of professionalism.
  • Proficient in standard office tools, including Excel, Access, Word and Power Point.  
  • PREFERRED SKILLS/EXPERIENCE:
  • Five (5) years Quality Engineering experience in a Class II or III medical device environment.
  • Ability to apply common sense understanding to carry out detailed written and/or oral instructions. 
  • Ability to quickly assess large amounts of information and data.
  • Ability to consider and evaluate the interrelationships of numerous factors and to select the best course of action is imperative. In the absence of sufficient information, sound intuitive judgment is crucial to reaching favorable decisions. Certain qualities, including self-confidence, motivation, decisiveness, and flexibility, as well as the ability to communicate effectively, and apply sound business judgment are important. The ability to define problems, collect data, establish facts, and draw valid conclusions.  
  • Ability to perform independently and as part of a team. 
  • Ability to lead, influence and negotiate with associates and colleagues at all levels and resolve issues. 
  • Ability to make rational, objective and appropriate decisions relating to company and department needs 
  • Ability to identify customer needs and issues and develop realistic solutions to meet needs and solve problems
  • Ability to communicate recommendations and decisions across a wide spectrum of the organization. 
  • Excellent oral, written communication and teamwork/relationship skills. 


PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


While performing the duties of this job, the employee is regularly required to use hands and fingers to handle or feel objects. The employees frequently is required to sit, stand, walk, reach with hands and arms, and talk or hear and will occasionally be required to bend, stoop, kneel and climb stairs.


Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.


WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The noise level in the work environment is usually quiet to moderate.


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.