Sr Quality Coordinator, HY

POSITION OVERVIEW:

Under general supervision, process, distribute and maintain controlled documentation using the organization’s document control system.  Provide support to assure compliance with applicable regulatory requirements.  Train employees across functional groups on document control processes, procedures, and standard protocol.   Maintain the corrective action and risk management systems as well as organize and facilitate the internal audit system.  Lead and/or participate in internal audits and provide support for external audits.

KNOWLEDGE, SKILLS, ABILITIES, EXPERIENCE & CERTIFICATES

Support the Quality department with maintaining compliance to regulatory or client specific requirements and interacting with regulatory contractors or labs. 
 
Coordinates all document control as it relates to ISO Certification, maintaining the master document list and Document Control Database/program.
 
Maintain and report to the Quality team our document control and CAR, KPI measurements.

Reviews documents for completeness (including proper formatting) to process through DCR system, ensures DCR forms are filled out appropriately (including proper reviewers/interested parties). 

Posts updated and/or new documents to the Share Point Hydranet; files related DCR documentation according to our procedures.

Schedules and organizes the Internal Audit system when necessary; may act as the lead in an audit.

Facilitates the follow-up of Supplier CAR’s and Risk’s, including verifications of completed CAR’s and Risk’s to ensure action taken. Maintain the CAR and Risk Mitigation database.  

Follows-up on CAR status with owners, with limited quality management attention, as required.
Provides support to implement corporate quality initiatives, including work with global Nitto partners and suppliers, as necessary.

High School diploma or GED and 8 years’ directly related experience; or an equivalent combination of education and experience. 

Working knowledge of administrative concepts, principles and methods including record-keeping techniques.

Strong multi-tasking skills, flexibility in responding to rapid change, dynamic processes, projects, and tasks and meeting deadlines while balancing job demands/pressure.

Ability to prioritize, work with and meet deadlines with a high-level of accuracy in a fast-paced office environment.

Handle a high-volume workflow within a manufacturing environment; understand and follow standard operating and safety procedures. 

Work independently and foster a cooperative spirit within a large and/or small team, strong data entry skills with a high degree of accuracy. 

Basic ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.

Intermediate ability to use Microsoft Office Suite (Word, Excel, Visio, PowerPoint, Teams, and Outlook) applications including JD Edwards. 
Basic to intermediate ability to apply critical thinking skills and deal with problems involving several concrete variables in standardized situations.  Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram forms. 

Quality Assurance concepts, principles and/or methodologies. 
Worked in an ISO 9001 (or similar) approved/certified environment for 5 years. 

American Society of Quality (ASQ) certification (such as Certified Quality Auditor - CQA), a plus. 

Internal certification as an ISO 9001 Lead Auditor.

Must be able to meet physical demands and work environment requirements.