What are the responsibilities and job description for the Quality Engineer position at ARCH?
Responsibilities
- Ensure that quality management system (QMS) requirements are adhered to in accordance with ISO 9001/AS9100 and ISO 13485.
- Promote awareness in all departments of regulatory and customer requirements.
- Become a consistent quality presence in the manufacturing process.
- Coordinate and conduct Material Review Board (MRB) activities.
- Perform capability studies to meet customer requirements.
- Prepare and conduct IQ/OQ of new and revised equipment as required.
- Conduct investigations and root cause analysis for the Corrective and Preventive Action (CAPA) system (Internal and Customer)
- Collect and help analyze quality metrics for both customer and Sr. Management needs.
- Assist with training programs to promote awareness and technical requirements for all employees.
- Maintain the calibration system.
- Must be able to handle multiple tasks and work in a fast-paced environment.
- Maintain a safe, clean and organized workspace.
- Miscellaneous quality tasks as required.
Skills, Education, and Experience
- Must have experience with the ISO 9001 Quality Management System standard at a minimum.
- Must have a thorough understanding of Geometric Dimensioning and Tolerancing.
- Must be able to read and interpret mechanical drawings, specifications and inspection instructions and determine product conformance based on such documents.
- Must be able to interact and communicate with coworkers at all levels of the organization with respect and dignity.
- Experience managing a calibration system and performing equipment calibration is a plus.
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