Quality Engineer, Senior

Pall Life Sciences Connects Talent with Opportunity!



Pall Corporation is a Fortune 1000 company and a global leader in the field of filtration, separation, and purification.  Every day our employees help make the world a better place… Pall’s filtration technologies help keep blood supply safe, help fight hospital infections, and are used in response to health crises and natural disasters around the world.  The company, although headquartered in East Hills, New York, has operations in every major country.  If you are interested in learning more about Pall Corporation, please visit our website at www.pall.com.

 

Our Opportunity

 

Our Life Sciences division offers a unique and challenging opportunity for a Senior Quality Engineer at our Covina, California location. This key position is responsible for handling investigation of customer complaints, implement CAPA’s, identify root causes and lead the quality continuous improvement efforts to attain total customer satisfaction.

Key Responsibilities

·  Investigate Product Occurrence Report (POR) by working with manufacturing personnel, Application Engineers, and Sales Account Managers to determine the scope, level of concern, corrective action, and action follow up. Communicate with customers on failures and application problems.

·  Develop biweekly POR reports to communicate concerns, trends, status, and pending actions to management.

·  Communicate to management and coordination of PORs that may require FDA notification or field action, maintain all documentation and files relating to complaints, updating and authoring SOP’s relating to complaint system, providing information and data to support FDA inspections and contacts.

·  Drive improvements in manufacturing based on customer complaints .

·  Analyze customer complaints and initiates corrective actions when appropriate.

·  Monitor system to prevent overdue action requests.

·  Work with process owners to resolve problems and implement long-term solutions within their areas.

·  Assist suppliers with corrective actions when necessary.

·  Verify supplier corrective actions through audits.

·  Provide support by performing capability studies for uncontrolled processes.

·  Track improvements made and translate into measurable metrics.

·  Visit suppliers to perform capability studies and ISO audits.

·  Work with Supplier Management Team to assess the possibility of Dock to Stock approach for major suppliers.

· Analyze data gathered from supplier audits to make recommendations on use.

·  Able to develop technical documentation such as Validation Protocols, technical/investigation reports, SOP, Validation Plans, Functional Requirements, Change Controls, etc.

 

The Talent We Need

 

·  Bachelor’s degree (BA/BS) in Engineering

·  Minimum of 3-5 years experience in quality assurance in the medical device industry.

·   Working knowledge of Quality Function Deployment (QFD), Fishbone diagram, Failure Mode Effects and Analysis (FMEA), Fault Tree Analysis (FTA)

·  Knowledge of DOE, Statistical Analysis, Quality System implementation, Quality Engineering techniques, regulatory compliance (GMP and ISO 9001) experience.     

·  Familiarity with Quality System Regulations QSR/QSIR, ISO 13485, Medical Device Directive (MDD), CE Marking and Canadian Medical Device Regulations is desirable.

·  Certified Quality Engineer (CQE) desirable.

·  Certified Six Sigma Green Belt desirable.

·  Able to travel internationally up to 20%.

 

 

 

If you are interested in this exciting opportunity, please send your resume

by email or fax to (626) 332-2518.

 

Pall Life Sciences is an Equal Opportunity Employer and a Drug-Free Work Place