Quality Engineer - Healthcare/Life Sciences at Plexus Deutschland GmbH

Neenah, Wisconsin, United States -

Full Time

Start Date

Immediate

Expiry Date

29 May, 26

Salary

116000.0

Posted On

28 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Customer Specification Compliance, Regulatory Requirements Adherence, Assembly Build Instruction Review, Engineering Change Order Approval, Master Validation Plan Creation, New Product Introduction Support, External Customer Audits, Internal Audit Activities, Corrective and Preventive Action (CAPA), Customer Quality Concerns Management, Quality Metric Data Analysis, Cost of Quality Reduction, Systemic Data Analysis, Structured Problem Solving, Experiment Design, Quality Management System Improvement

Industry

electrical;Appliances;and Electronics Manufacturing

Description

About us: 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, including advanced surgical systems, diagnostic instruments, healthcare imaging equipment, mission critical aerospace systems, and electric vehicle (EV) charging solutions. Visit Plexus.com to learn more about our unwavering commitment to our vision. 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. For more information, visit our US benefits website at usbenefits.plexus.com. Our commitment to pay range transparency fosters an equitable workplace, where everyone can feel valued. 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. Salary Range: $77,400.00 - $116,000.00 Purpose Statement: The Quality Engineer - Healthcare/Life Sciences ensures products comply with customer specifications, industry standards, regulatory requirements and Plexus standards. They will ensure Assembly Build Instruction (ABI)s comply with specifications and standards. Approve all changes and deviations from established guidance, including Engineering Change Order (ECO)s. Lead creation and maintenance of the Master Validation Plans, when required, and ensure compliance. Support creation and execution of documents for New Product Introduction (NPI). Serve as the Plexus lead to support external customer audits and internal audit activities. Support recertification and surveillance Quality Management System (QMS) audits. Lead product-related Corrective and Preventive Action (CAPA) discussion and closure. Key Job Accountabilities: Serve as the primary customer contact for quality-related issues, including specification inquiries and audits. Lead response and actions associated with customer quality concerns, including complaints, disclosures, and inquiries. Engage the Process and/or Product Engineer and other Subject Matter Experts (SMEs) to address customer quality concerns. Lead creation of customer defined quality reports. Lead Corrective and Preventive Action (CAPA) development in response to customer request. Provide feedback and documentation to the customer as required. Provide technical training, leadership, guidance and direction to regional and site management and stakeholders. Ensure continuous quality compliance during manufacturing operations. Monitor on-going manufacturing operations to ensure quality issues are quickly addressed; provide quality alerts and lead containment and purges, when required. Lead the development of the inspection strategy for receiving inspection, pre-ship inspection, and out-of-box-audits. Ensure Certificates of Compliance are created and maintained, including documentation of deviations. Ensure creation and maintenance of manufacturing quality history documentation, as required. Yield customer Parts Per Million (PPM) to reduce Cost of Quality in order to deliver customer excellence and achieve Plexus’ enduring goals. Lead analysis of quality metric data and identify opportunities to reduce scrap, rework and Clinical Risk Group (CRG)s. Collaborate with the Process and/or Product Engineer to implement improvements. Lead Corrective and Preventive Action (CAPA) development for repeat or systemic issues as well as ensuring implementation. Provide support and leadership in order to effectively design, develop, monitor, maintain, and continuously improve the quality management system in alignment with Plexus strategies and values to ensure services are capable of meeting business needs. Education/Experience Qualifications: Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or equivalent work 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: Ability to work well in fast-paced manufacturing environment. Strong ability to identify and solve problems proactively using structured problem solving tools, including making timely and effective decisions. Apply systemic data analysis and problem solving to address a full range of technical and organizational problems with creativity, imagination, confidence and responsibility. Ability to design and conduct experiments, as well as to analyze, interpret, validate, and communicate data to key stakeholders. Ability to seek out best practices and apply them within their assigned area. Ability to design a system or process to meet desired needs within realistic constraints such as economic, efficiency, repeatability, environmental, health and safety. Includes documentation and controls to ensure long term sustainability. Ability to become a Subject Matter Expert for an assigned system or process. Ability to coach and mentor technicians and other support staff within assigned areas of expertise. Ability to operate effectively in a cross-functional team environment. Ability to effectively lead projects involving cross-functional team members. Physical Requirements: Role will support operational teams in a manufacturing environment with required personal protective equipment. Facilities include comfortable temperatures, repetitive low noise level and suitable lighting for required tasks. May require walking, standing and sitting, using a computer, and other office equipment. Direct interaction with people and equipment is event driven and will include activities related to inspecting, qualifying, troubleshooting and improving jigs, fixtures, and manufacturing methods using different types of components or material. Role may require working individually on tasks with a prolonged focus on written material, working collectively as part of a team of various disciplines and backgrounds and working in multiple software systems. 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.

Responsibilities

The Quality Engineer ensures products meet customer specifications, industry standards, and regulatory requirements, while also approving changes and leading the creation and maintenance of validation plans. Key accountabilities include serving as the primary customer contact for quality issues, leading CAPA development, and driving continuous quality compliance during manufacturing operations.