Quality Associate

Job Full Description

 Perform incoming inspection on purchased components and raw materials against drawings, specifications, and approved sampling plans, and disposition nonconforming material per procedure.*    Perform in-process inspections at defined stages of microwave ablation generator and sterile probe manufacturing, verifying build steps and specifications are met before product moves to the next operation.*    Perform final/finished device inspection and release activities, confirming devices meet acceptance criteria before they're released to distribution.*    Use calibrated measurement equipment (calipers, micrometers, gauges, and other tools specific to the product line) accurately and maintain calibration awareness for equipment in use.*    Complete and maintain accurate, legible, GDP-compliant inspection records and device history record (DHR) documentation that will hold up under audit.*    Identify and document nonconformances, and support root cause discussions with manufacturing and quality engineering when patterns emerge.*    Support internal audits, external audits, and inspections by knowing your work area, procedures, and records cold.*    Follow and help maintain a clean, organized, ESD- and cleanroom-appropriate work area consistent with our quality system requirements.What We're Looking For - Must-Haves*    1+ years of experience performing quality inspection (incoming, in-process, or final) in a regulated manufacturing environment - medical device, aerospace, automotive, or similar.*    Ability to read and interpret engineering drawings, GD&T basics, and written work instructions accurately.*    Hands-on experience with standard inspection/measurement equipment (e.g., calipers, micrometers, height gauges, or comparable tools).*    Working knowledge of good documentation practices (GDP) - accurate, contemporaneous, legible records.*    Comfort working under a formal quality management system and following documented procedures precisely, including when a procedure seems slower than the shortcut.*    High school diploma or equivalent; ability to sit, stand, and use close-focus vision for extended inspection tasks.Nice-to-Haves*    Experience in a Class II or Class III medical device environment under FDA 21 CFR 820 and/or ISO 13485.*    Experience inspecting sterile or cleanroom-manufactured products.*    Familiarity with statistical sampling plans (e.g., ANSI/ASQ Z1.4).*    Experience using an electronic quality management system (eQMS) for inspection records or nonconformance documentation.


Madison, WI
2549
2418 Crossroads Drive
Suite 1800
Madison, WI 53718