About the position
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.
Responsibilities
- Manage Quality Engineer functions to ensure products meet specifications and regulatory requirements.
- Communicate and collaborate with management to improve quality direction.
- Work with all departments to promote continuous improvement in quality.
- Resolve quality problems with customers, vendors, and personnel.
- Oversee staffing, development, training, and performance management of Quality Engineer Department personnel.
- Build relationships with customers to enhance product quality and satisfaction.
- Develop and implement reliability analysis and validation protocols.
- Support engineering and manufacturing teams with validation strategies.
- Provide status updates to upper management and escalate issues as needed.
- Trend, analyze, and report on quality data to improve product quality.
- Perform audits of Master Device Record Documents.
- Collaborate with various stakeholders to resolve quality issues and implement corrective actions.
- Ensure regular and reliable attendance.
Requirements
- Bachelor's degree in a related area preferred.
- 3-5 years of experience in an engineering capacity post-degree.
- Minimum of 2 years in an engineering supervisory or management role.
- Experience in ISO 13485, ISO 14971, or similar quality management systems.
- Experience with qualifications and validations for processes, equipment, and test methods.
- Cross-functional team experience and people management skills.
- Ability to manage multiple priorities simultaneously.
- Experience interfacing with auditors or regulators during audits.
- Experience with Data Analysis, Statistical Analysis, and Process Improvement Tools.
Nice-to-haves
- Strong organizational abilities.
- Ability to lead and influence others.
- Experience in coaching and mentoring high-performing teams.
- Ability to solve practical problems with limited standardization.
- Strong verbal and written communication skills.
Benefits
- PPO/HMO Health Insurance
- Dental Insurance
- Vision Insurance
- Flexible Spending Account (FSA)
- Life Options
- Long-Term Disability (LTD) and Short-Term Disability (STD) options
- 401(k) plan
