Quality Systems Analyst

Plexus • Nampa, ID

1d

About The Position

Manage, support or coordinate Corrective and Preventive actions to ensure timely response, follow through, and appropriate reporting to management. Work on special projects as requested to improve the quality management system, which may include assisting with process validations, or documentation such as assembly build instructions, device travelers, certificates of compliance, complaint files, DMRs, DHRs, etc. Assist to establish regulatory guidelines and industrial standards in quality system and work with site quality managers to ensure compliance at sites/region. Supports the design and installation of the quality system. Assists to communicate quality system and regulatory requirements with internal customers. Bachelor's Degree with 2 or more years of related experience is preferred. An equivalent combination of education and/or experience will be considered." A combination of education, experience, and time in field will be taken into consideration, and internal candidates may have distinct requirements tailored to their demonstrated skills and contributions within the organization. Employee must be self-motivated with the ability to work independently and in a team environment. Good oral and written communication skills are necessary. Attention to detail, good problem solving skills, and computer literacy are essential. Project management and knowledge of ISO 9001, ISO 13485 and AS9100 a benefit, but not required. Professional office environment with suitable lighting, comfortable temperatures, and low noise level. May require prolonged periods of sitting at a desk, using a computer, and other office equipment. Minimal physical activity is generally involved, emphasizing the importance of good posture and ergonomic workplace arrangements. Less than 40%

Requirements

• Employee must be self-motivated with the ability to work independently and in a team environment.
• Good oral and written communication skills are necessary.
• Attention to detail
• Good problem solving skills
• Computer literacy

Nice To Haves

• Project management
• Knowledge of ISO 9001
• Knowledge of ISO 13485
• Knowledge of AS9100

Responsibilities

• Manage, support or coordinate Corrective and Preventive actions to ensure timely response, follow through, and appropriate reporting to management.
• Work on special projects as requested to improve the quality management system
• Assist to establish regulatory guidelines and industrial standards in quality system and work with site quality managers to ensure compliance at sites/region.
• Supports the design and installation of the quality system.
• Assists to communicate quality system and regulatory requirements with internal customers.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees