Quality Engineer II

ARCH•Kenosha, WI

17h

About The Position

This role involves leading quality control programs to ensure products meet FDA and ISO standards, investigating customer complaints, and assisting with audits. The Quality Engineer II will be responsible for document control, reviewing and revising the Quality Management System (QMS), and providing inspection throughout the production cycle. This position also involves creating and updating work instructions, directing process/equipment validations (IQ, OQ, PQ), and reviewing customer contracts. Additionally, the role includes creating PPAP documentation, directing inspection and testing activities, training other departments on quality standards, and working with suppliers to ensure the quality of purchased parts. A key focus is on continuous improvement, reducing scrap, waste, and costs. The position requires reliable attendance and may involve travel to other facilities or customer/vendor sites. Other duties as assigned.

Requirements

Bachelor’s degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, or a related field preferred or equivalent experience
Five to seven years of experience in medical device manufacturing industry and in the quality engineering role, and/or training, or equivalent combination of education and experience.
Knowledge of the medical device manufacturing industry is highly preferred.
Experience with CNC machining and mechanical inspection is preferred.
Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations.
Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M.
Familiarity with test methods and standards for the design, verification, and validation of medical device products.
Ability to read, analyze, and interpret common scientific and technical manuals, training materials, financial reports, and legal documents (specifically in English).
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community (specifically in English).
Ability to communicate effectively with tact, respect and professionalism within all levels of the organization.
Must work responsibly with or without supervision using effective communication skills; able to collaborate with various departments and all levels of team members.
Professional and working knowledge of Microsoft office and its applications (Word, Excel, Power Point, etc.), e-mail, communication platforms (Zoom, Teams).
Knowledge of manufacturing software and ERP systems (EPICOR is strongly preferred).

Nice To Haves

Relevant certifications demonstrating applied understanding of medical device quality system requirements, such as AAMI Quality System, Certified ASQ or ISO Lead Auditor and Regulatory Affairs Professional Society (RAPS) preferred.
GD&T certifications are highly preferred.

Responsibilities

Plans, coordinates, and directs quality control programs designed to ensure continuous production of products consistent with established FDA and ISO standards.
Investigates and addresses customer complaints (CAPA) regarding quality.
Assists with internal/external audits of the Quality Management System (QMS) to ensure compliance to procedural, customer, and regulatory requirements.
Fully versed in Document Control processes and procedures.
Assists in reviewing and revising processes within the QMS (Quality Management System).
Provides inspection activity for products throughout the production cycle.
Creates, implements, updates and maintains work instructions, partnering with the Engineering and other departments.
Creates and directs process/equipment validations (IQ, OQ, PQ).
Reviews customer contracts (purchase orders, regulatory requirements, blueprints).
Creates PPAP documentation (GR&R, control plans, first article inspection, criteria, etc.).
Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products.
Trains quality and other departments to achieve quality standards (visual and dimensional).
Works with suppliers to ensure quality of all purchased parts for company use.
Helps reduce scrap/waste, cost, time; drives for continuous improvement.
Reliable, timely, ethical and consistent attendance.
Travels to another facility and/or customer/vendor sites based on company needs.
Other duties as assigned.