Quality Assurance Manager

4 weeks ago


Bowling Green, Kentucky, United States Inova Health System Full time

Quality Assurance Manager

We are seeking a Quality Assurance Manager to join our team at Inova Health System. This role will be responsible for developing and maintaining a quality system to ensure that all products meet certain specifications and achieve superior quality levels.

The Quality Assurance Manager will be responsible for:

  • Developing, implementing, and overseeing quality production programs to ensure that all manufactured products meet quality standards and/or corporate specifications.
  • Ensuring conformity of purchased material and final products to quality standards.
  • Analyzing routine tests, inspection forms, and/or charts to monitor all aspects of quality.
  • Inspecting all returned products.
  • Investigating all customer complaints/returns and reporting the findings to Department Manager and Plant Manager.
  • Responding to customer complaints/returns.
  • Ensuring that all necessary paperwork is filled out and the product disposition is completed to its final end.
  • Reviewing all items in QA Quarantine to ensure actions taken to correct and prevent occurrence.
  • Assisting in the final disposition of product being held.
  • Identifying quality problems and determining the cause in order to prevent reoccurrence.
  • Initiating CAPAs as needed to document Corrective and Preventive Actions taken.
  • Providing monthly return and quarantine reports including product disposition to Plant Manager, production managers, and corporate.
  • Providing monthly production reports to Plant Manager and production managers.
  • Providing quality testing for trials, customer requirements, or other projects as necessary.
  • Preparing all necessary reports as required by customers, staff personnel, and management.
  • Providing technical assistance to Sales Department and visiting customers whenever necessary.
  • Meeting with vendors, customers, quality representatives, and Company personnel to discuss and resolve quality problems as required.
  • Ensuring Certificate of Analysis provided when order requires.
  • Coordinating Quality Coordinator activities and quality training programs.
  • Monitoring, calibrating, and requesting maintenance as needed on Lab testing equipment.
  • Ensuring facility's quality management system (QMS) is ISO 9001:2008 or relevant version compliant.
  • Preparing for and representing Company during ISO 9000 internal and external audits and/or assessments.
  • Developing procedures, work instructions, and forms as needed to achieve proper QMS.
  • Revising Quality Manual as needed.
  • Ensuring quality corrective actions, preventative actions, and continuous improvement activities are documented.
  • Overseeing the plant's SQF program.
  • HACCP certification required.
  • As SQF site practitioner, preparing for and representing Company during internal audits and/or assessments.
  • Ensuring policies, procedures, work instructions, forms, and records for SQF requirements are maintained.
  • Responsible for validating changes to food safety fundamentals and food safety that impacts the suppliers' ability to deliver safe food.

Qualifications & Requirements:

  • College degree or 3-5 years' experience in a related field, desirably in a manufacturing environment.
  • Firm knowledge of ISO standards with previous ISO experience (min. 2 years) in engineering or manufacturing.
  • Previously demonstrated knowledge of Document and Data Control, Management of Quality Records, Internal Auditing, preparation of procedures and work instructions, and other quality practices.
  • Proven ability to train and lead other employees in the implementation of a Quality System.
  • Requires the following skills:
    • Good communication skills.
    • Ability to plan and organize quality system activities.
    • Experience with training, motivating, and leading other employees.


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