Quality Systems Manager

WHO WE ARE 

We’re a global team of over 20,000 engineering, manufacturing, supply chain and sustaining service experts who partner with customers to bring their products to life through inspired innovation and world-class customer service. 

From surgical devices and health monitors to warehouse robotics and space products, we partner with our customers to help create the products that build a better world.

Whether you’re looking to start, make a change or advance your career, find your path at Plexus Corp. and make an impact.

WHY WE LOVE IT 

Engaging and challenging projects that fulfill and develop you. People that inspire and empower you to realize your full potential. Leadership and development programs to support your career goals.

We believe that our people create our best Plexus. At Plexus, we value the ideas generated by our collective uniqueness and recognize that the diverse backgrounds, life experiences and perspectives of our team members enable us to create the innovative products that build a better world. Because of this, we encourage people of all backgrounds to apply to our positions, and will look at candidates holistically, balancing work, education and additional experiences.

HOW YOU WILL DO IT

Purpose Statement:  The Quality Systems Manager leads the execution of the Quality Management System (QMS) processes in order to ensure compliance with standards and regulations for the assigned industries in order to drive Plexus towards achieving zero defects. Market sectors include but are not limited to Medical, Aerospace/Military/Defense and Industrial products. This role oversees key quality systems processes such as management review, Corrective and Preventive Action (CAPA), document control, non-product software validation (NPS) and risk management Accountable to drive continual improvement of the QMS. This role also contributes experience in establishing, implementing and maintaining quality objectives and goals. 

Key Job Accountabilities: 

• Understanding, implementation and maintenance knowledge of all applicable industry standards as required, including ISO 9001, ISO 13485, QSR, ITAR, AS9100, NADCAP, etc. Lead the execution of the QMS processes for these various standards and regulations to assure consistent and high quality execution. 

• Work with Site Quality and Corporate group(s) to understand and develop quality regulatory requirements and compliance strategies governed through management review and oversight. Support and assist with continuous improvement of quality systems as applicable. 

• Provide strategic risk management, governance and oversight of the core Quality System processes. This includes establishing goals, targets, measuring performance and initiating improvement to ensure added business value and support of quality objectives. 

• Acts as a company SME for the CAPA System and drives initiatives to identify and solve technical and procedural deficiencies to improve productivity and compliance. Audits, mentors and calibrates personnel working within the CAPA system in order to achieve and maintain a high level of understanding of the process and expected outcomes.

• Serve as a liaison for teams within Plexus to provide oversight, interpretation and guidance on NPS standards and regulations, ensuring Plexus maintains a compliant and efficient NPS process.

• Responsible to exemplify and hold their team accountable to demonstrating the Plexus Core Values. Leader will focus on evaluating potential, driving succession planning, and ensuring their employees receive the development and coaching required to realize their full potential. 

Education/Experience Qualifications: 

• Bachelor’s degree and a minimum of 5 years of experience in the related field, or a Master’s degree and at least 3 years of relevant experience. May require previous supervisory experience. 

• 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:

• Advanced decision making skills and problem solving skills. Advanced verbal and written communication skills including the ability to effectively interact, influence and build consensus with internal and external teams. 

• Strong presentation skills and the ability to represent Plexus Corp. in a professional manner. Must be able to build collaborative relationships with internal and external customers and have the ability to work with people at all levels of the organization. 

• Must have the ability to manage multiple tasks in fast paced environment and the ability to work with cross-organizational teams. General computer skills required. 

• American Society for Quality (ASQ) Certified Quality Manager, Engineer or Auditor a plus. Preferred work experience with FDA Assessors and/ or other Regulatory Affairs professionals. 

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 [email protected]. Please include your contact information and clearly describe how we can help you.

The email address above is for accommodation requests only and cannot be used to inquire about the status of applications.

Some offers of employment are contingent upon successfully passing a drug screen and upon completion of a confidentiality agreement.
Our Values and How We Lead behaviors guide our processes. Plexus does not make employment decisions based on race, color, religion, national origin, sexual orientation, gender identity, disability, or veteran status. We are proud to be an Equal Opportunity Employer (EOE) and encourage all to apply today!