JOIN OUR OUTSTANDING TEAM!
3 day work week to assist with a better work-life balance!
Available shift: Thursday-Saturday (Days) 7am-7pm.
Climate Controlled Facility!
Coordinates activities of workers in the Quality Department in the
areas of staffing, material requirements, documentation, productivity,
safety, and training. Works with the Quality Control Manager to
proactively lead the quality system efforts at Katecho through
monitoring of production operations, and adherence to and
administration of the ISO 13485 and FDA, Title 21 Part 820, QSR SOP directives.
PRIMARY DUTIES AND RESPONSIBILITIES
- Lead the employees of the quality area by example in the areas of
attitude, work quality, work ethic, dependability, and company loyalty.
- Work on continuous improvement of the quality system through
monitoring of production operations, personnel management, and
adherence to and administration of the Katecho QMS standards within
ISO 13485 and FDA, Title 21 Part 820, QSR guidelines.
- Work with other departments to determine the root cause and
solve problems involved with product quality.
- Effectively lead and assist the Quality Department personnel
working in the manufacturing areas of Katecho to include receiving,
converting, gel, print, and assembly.
- Expedite workflow.
- Insure product is inspected in a timely and accurate manner in
accordance with Katecho quality standards, ISO 13485 and FDA, Title
21 Part 820, QSR.
- Train quality employees reporting to Supervisor.
- Develop work instructions and request documentation changes as required.
- Monitor the completion of necessary documentation.
- Work with the following employee issues according to company
policy and in conjunction with Human Resources:
- Issue employee reviews according to guidelines.
- Track employee attendance.
- Resolve both minor and major employee conflicts.
- Issue employee discipline, both informal and formal.
- Ensure the department follows quality policies, human resource
policies, safety policies, and manufacturing rules and guidelines.
- Communicate and work together with other departments as required.
- Enforces decisions regarding inspection and inspection plans.
- Notifies QC Manager of any defective product that may have gotten
past their area of concern or of any changes that might be to the
detrimental to the Company or Customer.
- Other duties and responsibilities may be assigned as required.
- Develop work instructions and request documentation.
- Shut down manufacturing processes or quarantine product for
reasons pertaining to quality.
- Request the use of necessary resources to complete prototyping.