2150 - 188 - QA Manager

DeRoyal is an Equal Opportunity/Affirmative Action employer. Interviewing and hiring practices at DeRoyal do not discriminate on the basis of race, color, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, genetic information, veteran status or any other category protected by law.

2150 - 188 - QA Manager

Come join our team!  DeRoyal's Plastics Group is looking for an experienced Quality Assurance professional to join our team in Powell, TN.  The ideal candidate will plan, coordinate, and direct quality assurance programs and helps to establish standards designed to ensure continuous production of products by performing the following duties.

Some key responsibilities include:

Serves as Management Representative with responsibility to ensure that the quality system is established, implemented and maintained in accordance with the applicable standards.

Interacts with all internal DeRoyal departments regarding various requirements with the Quality System. 

Manages external and internal audits at production facilities to ensure compliance with applicable standards are demonstrated through explanation and presentation of quality system documentation and records.  These standards include the FDA Quality System Regulation, ISO 13485 Quality Management System Standard and other regulatory requirements relative to quality systems.

Ensures corrective and preventive actions for internal and external audit findings are implemented with corrective actions with verification of effectiveness.

Conducts corrective and preventive action meetings at plants.  Prepares and presents information for the meetings.   Reviews and evaluates complaint reports and investigation process for the complaint.  Communicates with customer and/or sales representative regarding corrective and preventive actions taken on reported complaints.

Works with Regulatory Affairs on Vendor and DeRoyal initiated recalls to determine products affected, customers affected and implements appropriate corrective and preventive actions.  

Conducts training on Quality System procedures and tasks.   Conducts DeRoyal New Hire training on Complaint Handling and QA/RA Department personnel.

Works closely with Plant Management and Quality Control staff to ensure Quality System is effective and implemented.   Manages the document control for the applicable division and/or plants.

Develops procedures and ensures compliance necessary for Quality System for compliance with applicable standards and regulations for the appropriate divisions.

Conducts Management Review meetings for plant level and division Executive level reviews.

Participates in Design Control Review meetings.   Works with Engineering, Regulatory Affairs, Marketing, Supply Chain Management & Plant Management on development of new products or changing of existing products (including research on testing, raw materials, use of product, applicable regulations, etc.)

Ensures that necessary validations are conducted on new products and significant changes to products as appropriate.

Develops test methods as required and ensures necessary testing is completed:  Bioburden, sterility, residual, environmental, package integrity, etc.

Analyzes statistical data on topics of interest.

EDUCATION and/or EXPERIENCE: Bachelor’s degree from a 4-year college or university required, or minimum 6-8 years minimum relevant experience required; or combination of education and/or experience.  Ability to speak Spanish a plus.

Some travel will be required.