WHO WE ARE
We’re a global team of over 25,000 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: Responsible for representing and supporting Plexus’ compliance to all applicable quality system regulations and standards. The senior level position should be used in sites without a Regulatory Compliance Manager, where responsibility will include leading and managing site level quality systems and regulatory concerns.
Key Job Accountabilities:
- Assures ongoing regulatory compliance for all documentation including Assembly Build Instructions, Device travelers, Certificates of Compliance, Compliant Files, DMR’s DHR’s, etc.
- Supports reviews of and compliance to external standards and regulations.
- Supports the design and installation of the quality system at the site.
- Support and or lead the training of all applicable standards (ISO, medical regulations, etc.).
- Supports the coordination of training to quality system documentation (SOP, Quality Plans, Work Instructions).
- Supports Process Validation/CAPA documentation and Implementation.
Additional Accountabilities:
- Manage the review / compare of internal documentation to external regulatory requirements.
- Lead the identification and training of techniques for validation of objective evidence.
- Leads the development of ESD, CAPA and Internal Audit training tools for the quality systems, including the use of audit trail documentation techniques in auditing.
- Supports the identification of applicable standards, necessary personnel, required documents and tools to support an audit.
- Lead the identification of various types of requirements such as standards, contracts, specifications, policies, required to support the audit objectives.
- Lead the identification of tactical methods for conducting an audit such as forward and backward tracing, discovery, sampling, data collection, etc.
- Leads the development of internal audit checklists.
- Manage the development and communication of an audit plan.
- Occasional travel may be required to meet the needs of the business (5%).
- Additional duties as assigned.
Education/Experience Qualifications:
- A minimum of a Bachelor’s degree in Engineering is preferred.
- Two (2) years of related experience is required.
- Individual typically has 2 to 4 years’ experience in an engineering, technical, quality function role or equivalent.
- Experience in product regulatory and medical device standards (FDA QSR, ISO 9001/13485/14001, etc.) is required.
An equivalent combination of education and experience sufficient to successfully perform the key job accountabilities may be considered.
Other Qualifications:
- Intermediate Computer Skills
- Intermediate Decision Making, Problem Solving Skills
- Intermediate Verbal and Written Communication Skills
- Advanced Execution
- Intermediate Operational and Industry Knowledge
- Advanced Decision Making & Problem Solving
- Intermediate Influence
- Advanced Communication
- Basic Workmanship Standard Knowledge
- Customer Focus
- General office equipment and materials
Work Environment:
- The work setting should consist of a manufacturing environment with suitable lighting, comfortable temperatures, and a moderate noise level.
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.
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!
Globally, our policy is to recruit people from wide and diverse backgrounds. However, our company does not typically undertake sponsorship, including for H-1B, TN, and other nonimmigrant visas. Additionally, certain positions require access to controlled goods and technologies subject to the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR). Applicants for these positions may need to be “U.S. persons.” “U.S. persons” are generally defined as U.S. citizens, nationals, lawful permanent residents (or, green card holders), individuals granted asylum, and individuals admitted as refugees.