Director of Quality
VP of Quality
Quality Systems Manager, Quality Control Manager
Directs all quality functions at Katecho to assure that all products
manufactured by the organization meet customer specifications and
regulatory requirements, and achieve superior quality and reliability
levels. Directs the Quality Department to effectively and efficiently
maintain and improve the level of quality at Katecho.
PRIMARY DUTIES AND RESPONSIBILITIES
- Is a key contributor to the overall quality direction of the
company. Communicates and works together with other management at
Katecho to maintain and improve the direction of the company.
- Develop and implement the quality assurance and quality control
programs at Katecho to ensure conformity of processes to established
a. Assure that the internal quality system meets the
requirements of ISO 13485, FDA Title 21 CFR Parts 11, 211, 820 etc.,
Canada MDD CANCMS, and Japanese Ministry of Health PDMR;
- Prepare for and represent the company as the designated management
representative during all ISO 13485, FDA Title 21 CFR Parts 11, 211,
820 etc., Canada MDD CANCMS, and Japanese Ministry of Health PDMR
and customer audits.
- Report to management on the performance of the QMS and the avenues
- Ensure the promotion of awareness of regulatory and customer
requirements throughout the organization.
- Proactively work and communicate with all departments at Katecho
in the area of quality with the goal of continuous improvement.
- Communicate with customers, vendors, quality representatives, and
company personnel to discuss and resolve quality problems as required.
- Assures customer surveys are completed
- Responsible for Quality component of Supplier Scorecard
- Oversee the management of the customer complaint process.
- Ensure complaints are processed and investigated in a
timely, accurate and efficient manner.
- Work with the customers to resolve the issues surrounding
the complaints, and institute corrective and preventative
actions resulting from the investigation of the complaint.
- Provide technical guidance and assist in the R & D
functions of the company.
- Oversee the management of the Quality Department(s)
personnel in the following areas (working with Human Resources):
- Development and training
c. Rewarding, reviewing, and disciplining
- Communicate and work together with other management and
departments at Katecho to maintain and improve the overall direction
of the company.
- Implement an effective internal auditing program.
- Other duties and functions may be assigned as required.
- Take necessary action required to remedy product quality problems;
such as quarantining product or shutting down production, etc.
- Initiate a product recall if required.
- Determine and request necessary resources (personnel, equipment,
supplies, etc.) to effectively run the Quality Department.
- Hire, reward, review, discipline, and terminate personnel in the
Quality Department according to company policy and applicable legal requirements.
- Provides direction on the quality assurance and quality control
functions of Katecho. This includes the organization and
scheduling of the department.
- Directs the quality assurance and quality control functions of
Katecho. This includes organization and scheduling of the department.
- Works together with other members of the management team to manage
the overall direction of Katecho.
- Must complete a Non-Compete Agreement and Patent Agreement.