Quality Systems Analyst

Quality Management Systems Compliance

At Plexus, our vision is to help create the products that build a better world. Driven by a passion for excellence, we partner with leading Aerospace/Defense, Healthcare/Life Sciences and Industrial companies to design, manufacture and service some of the world's most transformative products.

When we invest in our people, we invest in building a better world. With a vision rooted in the wellbeing and inclusive engagement of our team members, our customers, their end users and our communities, people are the heart of what we do and who we are. It is our values that unite us and guide us in everything that we do, including how we operate, behave and interact to foster a workplace where every team member feels valued and empowered to contribute their best.

Our values include: Growing our People, Building Belonging, Innovating Responsibly, Delivering Excellence and Creating Customer Success.

As a team member, you will engage in impactful work through global collaboration and the use of emerging technologies, join an inclusive culture where every team member is valued and working toward a greater purpose, and be empowered to reach your full potential through various development programs designed to accelerate your growth.

Plexus offers a comprehensive benefits package designed to support team members' wellbeing, including medical, dental, and vision insurance, paid time off, retirement savings, and opportunities for professional development. We also prioritize work-life balance and offer a variety of perks to enhance the team member experience.

The annual compensation range for this position is stated below. The salary offered within this range will be based upon the geographic location, work experience, education, licensure requirements and/or skill level.

$58,100.00 - $87,100.00

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.
• 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.

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.

We are pleased to provide reasonable accommodations to individuals with disabilities or special requirements. If you need an application accommodation, please contact us by email at GHQ.TA@plexus.com. Please include your contact information and clearly describe how we can help you. This email is for accommodation requests only and cannot be used to inquire about the status of applications.

We are an Equal Opportunity Employer (EOE) and do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Some offers of employment are contingent upon successfully passing a drug screen and/or background check.