Engineer, Sr Quality Sys - 100437 - Quincy/Marina Bay - 0300 Posted Date: August 22, 2013



Job Description

Purpose Statement
 

 





Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Provide quality engineering support within technical development concepts, regulatory, operational, or system/services support.






Key Responsibilities











 






Applies technical quality engineering principles to assigned projects, products or sites and guides them into implementation.
Provide project direction, coaching, and mentoring for engineering and technical team personnel as appropriate.
Investigates, identifies, and implements best-in-class Quality Engineering practices as requested by management.
Identifies and implements effective process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Potentially act as team member in supporting quality disciplines, decisions, and practices.
Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
Analyze Quality data for management reporting, and advise management on potential improvements or enhancement to quality systems and processes in the company. 
Other Duties as Assigned.







Quality System Requirements






In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:





 






Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
Establishes and promotes a work environment that supports the Quality Policy and Quality System.







Management Requirements











 






Not applicable.







Requirements







Bachelores of Science in related discipline, 6 years'' experience in FDA regulated environment.

 
Preferred
·        ASQ Certification
·        Demonstrated experience using PDM, e-CAPA , and other quality related systems.

Experience Required

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