Senior Quality Engineer

Plan and conduct quality control and quality assurance activities

Office

We have an opportunity for a Senior Quality Engineer to interact with internal departments to plan and conduct activities concerned with the quality control and quality assurance of industrial processes, materials, and products, and leads problem-solving activities to improve manufacturing processes. This position will work with external customers, suppliers and internal personnel to complete Advanced Product Quality Planning (APQP) requirements and medical device process validation on all new and/or product changes, and corrective action implementation.

Job Description

Primary responsibilities include the following:

Coordinate Automotive PPAP and Medical Validations for new and revised products. Will regularly
compile PPAP and Validation reports, and develop procedure manuals.
Perform quality-engineering reviews of design documentation for compliance with stated requirements,
including customer quality manuals and company quality records.
Collaborate with Layout Tech and Project Engineer to define and review the dimensional inspection
process including fixture development, inspection work instructions and TMV (Test Method Validation).
Apply statistical process control (SPC) methods for analyzing data to evaluate the current process and
process changes. Conduct data analysis utilizing Minitab, Microsoft Excel or other analytical software or
methods as necessary.
Communicate with customers to resolve quality concerns and implement corrective actions designed to
resolve and prevent a repeat of the concern.
Use a structured problem solving approach including problem definition, data collection and analysis,
escalation identification and solution recommendation.
Update and maintain quality instructions for the manufacturing process.
Conduct internal audits of quality procedures in compliance with quality standards.
Support the Continuous Improvement initiatives of the company.

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!

A minimum of seven years of combined quality and manufacturing experience is required. Experience in
custom injection molding is preferred.
Experience applying statistical techniques and methods is required.
Strong verbal, written and interpersonal communication skills required.
Working knowledge of applicable regulations and standards such as FDA, ISO 13485, IATF 16949,
MedAccred, etc.
Working knowledge of process validation and verification activities, including Risk analysis and mitigation
techniques including Process FMEA (Failure Modes and Effects Analysis), Process Flow Charts and Control
Plans.

Must be able to work independently as well as part of multifunctional teams including COPQ (Cost of Poor
Quality). Demonstrated experience in leading, mentoring, coaching, and guiding team members is
required.
Must be able to apply basic algebra and geometry concepts, SPC and other analytical calculations; plus
have strong blueprint reading skills including tolerance review and knowledge of GD&T principles.
Advanced computer proficiency in a Windows environment is required; plus the ability to utilize problemsolving and statistical software programs, Minitab preferred. Experience with Delmiaworks (formerly IQMS) or related ERP/MRP manufacturing software is strongly preferred. Proficiency with Solidworks/CAD is a positive.
This position works onsite daily at Kaysun’s main office in Manitowoc, WI. Remote work option is not
available on a regular basis.
Must be authorized to legally work/reside in the U.S. without employer sponsorship.