Quality Engineering Manager | M - F | Pay Based on Experience

SUMMARY

Manages Quality Engineer functions at Katecho to assure that all products manufactured by the organization meet customer specifications, regulatory requirements, and achieve superior quality and reliability levels. Manages the Quality Engineer Department to effectively and efficiently maintain and improve the level of quality at Katecho.

• 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.
• Proactively works and communicates with all departments at Katecho in the area of quality with the goal of continuous improvement.
• Communicates with customers, vendors, quality representatives, and company personnel to discuss and resolve quality problems as required.

• Oversees the management of the Quality Engineer Department personnel in the following areas (working with Human Resources):
• Staffing
• Development and training
• Rewarding, reviewing, and disciplining.

• Builds relationships with Katecho’s customers, not only profitable for the company in terms of the product sold but also rewarding to the customer in terms of the quality of the product purchased.
• Develops and implements reliability analysis, design, validation, and assessment method protocols and reports to support successful new product introductions and sustaining product changes.
• Provides insight to new product transfer teams in the area of design manufacturing process control, process verification and validation, and risk management.
• Provides support to engineering and manufacturing teams in determining validation needs, strategies, and requirements.
• Provides upper management with status updates on assigned responsibilities and goals and escalates issues in a timely fashion.
• Trends, analyzes, and reports on quality data in order to improve product quality; develops recommendations for compliance with customer requirements, applicable regulations, and/or company SOPs.
• Performs audits of Master Device Record Documents.
• Collaborates with operations, engineering, customers, and vendors to coordinate and resolve quality related issues and implement corrective/preventive actions as to prevent reoccurrence.
• Regular and reliable attendance is an essential function of this job. Punctuality and regular attendance are crucial for efficient plant operations, safety, and morale.
• Other duties and functions may be assigned as required.

AUTHORITY

• Takes necessary action required to remedy product quality problems, such as quarantining product or shutting down production, etc.
• Initiates a product recall if required.
• Determines and requests necessary resources (personnel, equipment, supplies, etc.) to effectively run the Quality Engineer Department. 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.

QUALIFICATIONS

1. Education and/or Experience

• Bachelor’s degree in related area preferred.
• Three to five years of experience working in an engineering capacity after having received degree.
• Minimum of two years of experience in an engineering supervisory or management role.
• Some quality assurance practices as they apply to individual unique products can be learned during on-the-job training, but overall capability in this discipline must be previously demonstrated.
• Experience working within an ISO 13485, ISO 14971, or other quality management system environment.
• Experience with qualifications and validations for processes, equipment, and test methods.
• Cross functional team experience and people management.
• Manage time working on multiple opposing priorities simultaneously.
• Experience interfacing with auditor or regulators during audits.
• Experience with Data Analysis, Statistical Analysis and/or Process Improvement Tools

2. Leadership Ability

• Strong organizational abilities.
• Able to lead and influence others in the areas of attitude, work ethic, dependability, and company loyalty.
• Coach, mentor, develop, hire, train, and manage high performing Quality Engineers to greater success and achievement.
• Must be able to pass a criminal background check.

3. Reasoning Ability

• Able to solve practical problems with a variety of variables in situations where only limited standardization exists.
• Able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

4. Language/Communication Skills

• Able to read, analyze, and interpret general business periodicals, reports, technical procedures, and/or government regulations.
• Able to write reports, business correspondence as well as internal procedures and instructions.
• Able to effectively present information and respond to questions from customers, managers, and employees. Strong interpersonal skills and presentation skills.
• Demonstrated verbal and written communication skills; ability to interact effectively both one-on-one and in groups.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals to perform the essential functions.

While performing the duties of this job, the employee is frequently required to stand, walk, sit, and operate a computer. The employee must be able to communicate with speech and hearing. Specific vision abilities required by this job include close vision and distance vision. The employee must be able to travel by air as well as ground transportation.

WORK ENVIRONMENT

Office environment with business casual dress. May require business attire.
Job Benefits:

PPO/HMO Health, Dental, Vision, FSA, Life Options, LTD/STD options, 401(k)

From: Katecho