Quality Management Systems Specialist

Quaker Houghton•Dayton, OH

2d•Onsite

About The Position

Responsible for supporting the effective functioning of the quality systems and programs in North America under direct supervision of the Manager Quality Assurance North America. Support the Quality Management System (QMS), its policies and programs. Coordinates and supports ISO 9001 and other QMS at Quaker Houghton locations. Supports the ISO QMS program with external audit registrar. Attends audits and management review meetings. Assists in developing and writing documents (Standard Operating Procedures, Quality Manuals, Work Instructions). Manages the document control program. Conducts Quality Assurance orientation and various training programs for new hires and other associates. Assists and coordinates Quaker Houghton’s QMS Internal Audit process: Develops annual internal audit schedule. Schedules annual internal audits at Quaker Houghton facilities with Quaker Houghton quality internal auditors, site management, and site representative. Conducting internal audits. Writes audit reports and conducts reviews with sites. Recommends corrective actions. Leads internal and external audits of the various quality elements Administrates Corrective and Preventive Action process Enters non-conformances into Quaker Houghton’s CAPA (Corrective and Preventive Action) system. Issues and documents Corrective Actions (CARs) stemming from customer complaints, audit non-conformances, process non-conformances which affect Quaker Houghton’s internal and external customers, processes, and interested parties. Reports on the status of CARs and follows up on outstanding actions. Other duties and responsibilities Generate various quality system reports. Assist process owners in developing meaningful metrics, root cause analysis for CARs, and implementation of corrective actions. Cooperate with various other Quaker Houghton departments and locations to build the Quality Culture within Quaker Houghton. Handles non-routine situations for review and approval by senior staff Independently reviews and monitors the status of controlled documents (i.e., SOPs, Specifications, Methods, Protocols, Training Materials, etc.) Deliver training for more complex/non-routine/individual/small group training Participate in and guide the development and instructional design of training offerings and materials Supports Management of Change review and approval Assists in developing user requirement specifications and conduct risk assessments Participates in oversight of Internal Audit and Supplier Quality Programs with guidance from management Participates in the development, implementation and monitoring of training programs Provides input for customer presentations to justify adoption of proposed projects and to demonstrate the benefits of successfully completed proposals.

Requirements

Support the effective functioning of the quality systems and programs in North America.
Direct supervision of the Manager Quality Assurance North America.

Nice To Haves

Experience with ISO 9001.
Experience with document control programs.
Experience conducting internal audits.
Experience with Corrective and Preventive Action (CAPA) systems.
Experience developing training materials.
Experience with Management of Change processes.
Experience with user requirement specifications and risk assessments.
Experience with Supplier Quality Programs.

Responsibilities

Support the Quality Management System (QMS), its policies and programs.
Coordinate and support ISO 9001 and other QMS at Quaker Houghton locations.
Support the ISO QMS program with external audit registrar.
Attend audits and management review meetings.
Assist in developing and writing documents (Standard Operating Procedures, Quality Manuals, Work Instructions).
Manage the document control program.
Conduct Quality Assurance orientation and various training programs for new hires and other associates.
Assist and coordinate Quaker Houghton’s QMS Internal Audit process.
Develop annual internal audit schedule.
Schedule annual internal audits at Quaker Houghton facilities with Quaker Houghton quality internal auditors, site management, and site representative.
Conduct internal audits.
Write audit reports and conduct reviews with sites.
Recommend corrective actions.
Lead internal and external audits of the various quality elements.
Administer the Corrective and Preventive Action process.
Enter non-conformances into Quaker Houghton’s CAPA (Corrective and Preventive Action) system.
Issue and document Corrective Actions (CARs) stemming from customer complaints, audit non-conformances, process non-conformances which affect Quaker Houghton’s internal and external customers, processes, and interested parties.
Report on the status of CARs and follow up on outstanding actions.
Generate various quality system reports.
Assist process owners in developing meaningful metrics, root cause analysis for CARs, and implementation of corrective actions.
Cooperate with various other Quaker Houghton departments and locations to build the Quality Culture within Quaker Houghton.
Handle non-routine situations for review and approval by senior staff.
Independently review and monitor the status of controlled documents (i.e., SOPs, Specifications, Methods, Protocols, Training Materials, etc.).
Deliver training for more complex/non-routine/individual/small group training.
Participate in and guide the development and instructional design of training offerings and materials.
Support Management of Change review and approval.
Assist in developing user requirement specifications and conduct risk assessments.
Participate in oversight of Internal Audit and Supplier Quality Programs with guidance from management.
Participate in the development, implementation and monitoring of training programs.
Provide input for customer presentations to justify adoption of proposed projects and to demonstrate the benefits of successfully completed proposals.