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Title

Quality Assurance Engineer 

Location Torrance, CA  
About the Organization Midmark Corporation brings efficient patient care to millions of people each day in the human and animal healthcare industries around the world. The most trusted name in medical, dental and veterinary healthcare equipment solutions, Midmark is committed to providing innovative products and services for the healthcare professional, integrating value-added technology into everything it does. With over 1,500 teammates worldwide, Midmark is dedicated to making a positive difference in the practice of healthcare. Headquartered in Dayton, Ohio, Midmark Corporation maintains five subsidiaries in the United States. To support international healthcare markets, it holds subsidiaries in the United Kingdom, India and Italy. For more information about Midmark, visit the company's Website at midmark.com.

Be Extraordinary.
Take a chance and step outside the box. No matter how big or small the step is, make it a step towards an extraordinary career with Midmark. We want you to reach your full potential because we realize our teammates are our most valuable assets. Wherever your passions lie, you can find challenging and rewarding work at Midmark.

Our Culture is Unique.
Because we care.« is not just words but the way we live. We make a difference each day and challenge ourselves to be better than the best. Our people choose us because of our reputation for excellence and our work environment in which our values are lived every day.
 
Description

  Quality Engineer (Manufacturing Focus) 

  
About the Organization - Quality Engineer (Manufacturing Focus) 
Midmark Corporation brings efficient patient care to millions of people each day in the human and animal healthcare industries around the world. The most trusted name in medical, dental and veterinary healthcare equipment solutions, Midmark is committed to providing innovative products and services for the healthcare professional, integrating value-added technology into everything it does. With over 1,500 teammates worldwide, Midmark is dedicated to making a positive difference in the practice of healthcare. Headquartered in Dayton, Ohio, Midmark Corporation maintains five subsidiaries in the United States. To support international healthcare markets, it holds subsidiaries in France, India and Italy. For more information about Midmark, visit the company’s Web site at midmark.com.
  
Be Extraordinary - Quality Engineer (Manufacturing Focus) 
Take a chance and step outside the box. No matter how big or small the step is, make it a step towards an extraordinary career with Midmark. We want you to reach your full potential because we realize our teammates are our most valuable assets. Wherever your passions lie, you can find challenging and rewarding work at Midmark.
  
Our Culture is Unique - Quality Engineer (Manufacturing Focus) 
Because we care™ is not just words but the way we live. We make a difference each day and challenge ourselves to be better than the best. Our people choose us because of our reputation for excellence and our work environment in which our values are lived every day.
     
Summary - Quality Engineer (Manufacturing Focus) 
Responsible for monitoring, testing and inspecting products to make certain they meet specified standards. Quality engineers test products to determine how long they will last, what part may break down first and how to improve product durability. They inspect product materials, mechanics and electrical systems. Responsible for not only finding defects, but also for finding the cause of the defect and develop a solution.
  
Responsibilities - Quality Engineer (Manufacturing Focus) 

  • Ensure maintained compliance to all applicable safety standards an safety requirements
  • Coordinates and participates with NPD team in design for compliance to safety standards un creating product model construction, charts, critical components lists and acts as a technical liaison and consultant
  • Coordinate and participate with NPD teams on risk management activities relative to safety standards
  • Manages the creation of required compliance documentation and test records
  • Conducts required product model compliance testing activities as specified hazard mitigation and safety compliance is maintained
  • Actively involved in the evaluation of product model design, ensuring that the product is safe and effective for productions and sale to the public
  • Coordinate activities with regulatory agencies as an integral process of evaluating product models for compliance to applicable standards
  • Root cause analysis and implementation of corrective action for process related concerns
  • Assist Quality manager in establishing, implementing and maintaining the quality management system
  • Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
  • Develop training to build quality awareness
  • Interface with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data
  • Support the Quality Inspectors to ensure that products and processes comply with the relevant requirements of the quality management system
  • Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions
  • Analyze failure, corrective and preventive action to respond to customer complaints
  • Create and maintain company quality documentation, such as quality procedures, etc.
  • Manage calibration program and activities
  • Responsible for planning, organizing and managing the overall activities of receiving / outgoing quality functions
  • Continuously improving QA receiving inspection process and procedures
  • Ensure timely resolution of supplier failure, corrective actions and preventive actions
  • Manage suppliers’ performance and conduct audits
  • Preparation of QA reports
 
Position Requirements

 Requirements Position Requirements - Quality Engineer (Manufacturing Focus) 
  
Qualifications - Quality Engineer (Manufacturing Focus) 

  • Thorough knowledge of current FDA, current Good Manufacturing Practices (GMP) and ISO 13485 and 14971 requirements. Strong knowledge in Design of Experiments (DOE), Statistical Process Control (SPC), Failure Mode & Effects Analysis (FMEA), and Gage Repeatability and Reproducibility (Gage R&R)
  • Ability to lead others on cross-functional project teams and collaborative projects. Ability to communicate effectively, both verbally and in writing. Ability to work well under pressure, to handle multiple projects, and to meet deadlines.  Ability to read and understand regulations and procedures
  • Must have excellent blueprint reading and interpretation skills as well as the ability to perform measurements to drawings as required. Strong knowledge in Geometric Dimensioning & Telebanking (GD&T)
  • Good leadership, analytical, written and interpersonal skills

  
Education/Experience - Quality Engineer (Manufacturing Focus) 

  • A Bachelor’s degree in mechanical engineering, electrical engineering or a related engineering field and 7 years of work experience in Quality in a GMP environment
  • Knowledge of FDA regulations and CE marking requirements
  • New product development experience
  • Certified Quality Engineer (CQE) preferred. Or an equivalent combination of training and experience 

We are an Equal Opportunity Employer.

Minimum travel

 
Full-Time/Part-Time Full-Time  
Shift Days  
Travel Requirements Minimum travel  
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.  

This position is currently not accepting applications.

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