Quality Systems Analyst II

Purpose Statement: Aid in ensuring compliance and continual improvement activities for the Plexus Quality Management Systems.

Key Job Accountabilities:

• Lead, manage and/or participate in internal and external audits for applicable market sectors including customer audits/visits, regulatory inspections and registrar/certification audits as requested. This may include creating and maintaining the internal audit schedule.
• 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.

Remain abreast of new and ever-changing applicable quality system standards and regulatory requirements.

Relevant standards may include ISO 9001, ISO 13485, AS 9100, Nadcap, ISO 14001, etc.

• Supports the design and installation of the quality system.

Assists to communicate quality system and regulatory requirements with internal customers.

Education/Experience Qualifications:

• Bachelor’s Degree with 2 or more years of related experience is preferred. An equivalent combination of education and/or experience will be considered.

Other Qualifications:

• 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.

Physical Requirements:

• 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.

Travel Requirements:

• Less than 40%

This document does not represent a contract of employment and is not intended to capture every possible assignment the incumbent could be asked to perform.