Senior Quality Engineer

Plan, coordinate, and lead quality engineering activities for industrial processes, materials, and products within assigned areas of responsibility.

Office

We have an opportunity for a Senior Quality Engineer to plan, coordinate, and lead quality engineering activities for industrial processes, materials, and products within assigned areas of responsibility. This position works directly with customers, suppliers, and internal teams to complete APQP, Automotive PPAP, medical validation, and corrective action activities for new and revised products.

Job Description

Primary responsibilities include the following:

Reviews product design, manufacturing, and quality documentation to ensure compliance with Kaysun standards, customer requirements, regulatory requirements, and applicable quality management system standards.
Develops, maintains, and continuously improves quality procedures, work instructions, and manufacturing quality documentation to support product quality and process effectiveness.
Coordinates APQP, Automotive PPAP, and medical validation activities for new and revised products.
Applies SPC and other statistical methods to analyze process data, evaluate process changes, and support fact-based decisions.
Conducts internal audits of quality procedures and supports compliance with applicable quality standards.
Supports MRB processes, including disposition, containment, and follow-up actions.
Leads and supports structured problem solving, root cause analysis, and corrective action implementation for internal and customer quality concerns.
Reports corrective action status to CARB (Corrective Action Review Board) and escalates risks or barriers as needed.
Collaborates with Layout Technician, Tooling and Project Engineer to define dimensional inspection methods, fixtures, inspection instructions, and test method validation requirements.
Participates in feasibility reviews for new and revised products.
Represents the company with customers and suppliers in a professional manner.
Supports, follows, and promotes all established safety policies and procedures.
Supports the Continuous Improvement initiatives of the company.
Maintains professional and technical knowledge via educational workshops, reviewing professional publications, establishing personal networks, and participating in applicable professional societies.
On-site regular and reliable attendance is required.
Performs other duties as assigned.

A Workplace With Integrity

Your voice is heard
Your ideas are welcomed
Your mind is challenged
You enjoy great benefits
You share our core values: optimism, innovation, and teamwork
You care that your employer follows green initiatives and has a culture of responsibility to the environment and community

We offer a flexible and empowering work environment.

We support and encourage lifelong learning and professional development.

We embrace continuous improvement at all levels of the organization.

We have fun and celebrate success!

Job Requirements & Working Conditions

A bachelor’s degree in engineering, Quality, or a related field is normally required. If non-degreed, must possess a combination of equivalent relevant education and experience
A minimum of seven years of quality engineering experience is required. Experience in custom injection molding is preferred.

Demonstrated experience with APQP, Automotive PPAP, medical validation, risk analysis, PFMEA, flow charts, control plans, and validation or PPAP reporting is required.
Working knowledge of applicable regulations and standards such as FDA, ISO 13485, IATF 16949, MedAccred, ITAR, and related requirements is required.
Experience applying statistical techniques and problem-solving methods, including SPC, root cause analysis, corrective action, 5 Whys, Fishbone, and 8D, is required.
Strong blueprint reading skills, including tolerance review and knowledge of GD&T principles, are required.
Must be able to use a scientific approach to define problems, collect and interpret data, and develop fact-based solutions.
Strong verbal, written, and interpersonal communication skills are required. Ability to effectively present to peers, managers, suppliers, and customers is required.
Demonstrated ability to collaborate with and facilitate cross-functional teams is required.

Advanced computer proficiency in a Windows environment is required, including Word, Excel, Outlook, Teams, and PowerPoint. Experience with IQMS or related integrated manufacturing software is strongly preferred. Experience with Minitab or related statistical software is preferred. Must be able to quickly learn new software.
Knowledge and experience using and programming inspection equipment, including CMM, vision systems, and hand tools, is preferred.
While performing the duties of this job, the employee is frequently required to talk and hear. The employee is frequently required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.
The noise level in the office work environment is low; when applicable, the noise level in the production work environment is usually moderate to loud.
Must be able to travel up to 10% of the time.
This position works onsite daily at Kaysun’s main office in Manitowoc, WI. Remote work option is not available on a regular basis.
Work Authorization: Applicants must be legally authorized to work now and in the future in the United States. Kaysun does not sponsor employment visas now or in the future.