What are the responsibilities and job description for the Quality Engineer position at Katalyst HealthCares & Life Sciences?
Responsibilities
- Assists in the implementation of, and compliance with, ISO standards.
- Assists in identifying customer-required quality compliance specifications and translating them into effective procedures, instructions, and training material.
- Develops and maintains quality procedures and instructions for engineering, material testing, and design and development projects.
- Maintains a controlled QMS document library.
- Supports Corrective Action efforts for problem identification, improvement, and prevention.
- Prepares material used to evaluate the effectiveness of the quality management system in support of management review meetings and in other.
- settings.
- Provides support for customer representatives regarding quality issues.
- Assist with the development and implementation of the overall quality management system to AS9100 and create inspection plans and processes for AS9102 compliance.
- Participate in the development of and utilize key performance indicators (KPI's) to achieve Quality goals.
- Works with suppliers to resolve or improve quality issues and to implement effective corrective action.
- Works with support service stakeholders, including Procurement, IT, Human Resources, Contract Administration, and Facilities to ensure a fully compliant management system environment.
- Supports engineers and technical staff in design and process validations, process control, process training, process improvement, and risk management.
- Coordinates process steps, standards and requirements, and infrastructure to enhance the existing quality management system.
- Other quality related responsibilities assigned by management.
- Bachelor's degree or higher in STEM focused area (science, technology, engineering, math) or other quality or management related field.
- Must be able to obtain/maintain DoD clearance.
- Experience with Quality Management processes in an environment compliant with ISO9001, AS/IA9100, or ISO standards.
- Working knowledge of desktop applications including MS Outlook, Word, Excel, and PowerPoint
- Excellent written and verbal communication skills.
- Good problem-solving abilities using systematic, logical, and sequential approaches.
- Self-motivation to take the initiative to complete tasks.
- Ability to work cooperatively in a team environment to reach common results and goals.
- ISO 19011:2018 Lead Auditor Certification.
- Sense of Urgency - Takes initiative to resolve problems/issues.
- Individual Accountability - Takes responsibility and consistently delivers on commitments.
- Builds relationships - Continuously fosters positive working relationships by developing win-win solutions.
- Analytical - Makes decisions to solve problems by using sound judgment.
- Sets High Standards - Demands excellence by continuously raising the performance bar.
- Attention to Detail - Utilizes established monitoring systems, records data accurately and in a timely manner, andensures accuracy of data.
- Communication - Effectively communicates verbally with others and in writing.
