Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Ensure that quality management system (QMS) requirements are adhered to in accordance with ISO 13485 and 21CFR 820.
- 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.
- Help to prepare and conduct IQ/OQ of new and revised equipment as required.
- Assist in 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 To perform the job successfully, an individual should demonstrate the following competencies:
- Must have experience with the ISO 13485 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.
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 with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally required to stand; walk and sit. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. Additional Notes ARCH Medical Solutions-Memphis is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Medical Solutions-Memphis are employed on an at-will basis. This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.