Quality Engineer

Filamatic•Baltimore, MD

68d•Onsite

About The Position

Filamatic, a division of National Instrument, LLC, is seeking a Quality Engineer with a broad scope of responsibility, overseeing quality from component arrival to final customer sign-off. This role is crucial for maintaining the company's reputation in the Pharmaceutical, Biotech, Diagnostic, and Cannabis industries. The Quality Engineer will act as the primary owner of the quality management system and the day-to-day quality representative across various departments, including shop floor operations, engineering, and customer interactions. This hands-on position offers significant ownership and direct impact on the quality of the machinery produced.

Requirements

Bachelor's degree in Engineering (Electrical, Mechanical, Industrial, Manufacturing, Mechatronics) or equivalent experience, OR an associate’s degree with significant relevant experience.
3–7+ years of quality engineering experience in industrial machine / capital equipment manufacturing (custom machinery, OEM equipment, or similar low-to-mid volume build environment).
Hands-on experience with incoming inspection and reading engineering drawings, GD&T, and inspection/measurement tools (calipers, micrometers, CMM a plus).
Hands-on experience with customer compliance documentation and responding to customer quality questionnaires/specifications.
Hands-on experience hosting or supporting customer audits and source inspections.
Hands-on experience defining and running Factory Acceptance Tests (FATs) and creating acceptance documentation.
Working knowledge of ISO 9001 (or equivalent QMS); familiarity with industry-specific standards relevant to our customers (e.g., ASME, FDA/GMP, CE/UL, sanitary/3A) is a plus.
Strong written and verbal communication skills.
Proficient with Microsoft Office and ERP/MRP quality modules; experience with inspection/quality software a plus.

Nice To Haves

ASQ certification (CQE, CQA, or CQT).
Experience in a small-company environment where the quality function is broad and hands-on.
Familiarity with welding quality (WPS/PQR/WPQ), NDT, or electrical/controls documentation.
Experience implementing or maintaining ISO 9001 certification.

Responsibilities

Establish and execute incoming inspection plans for purchased components, fabricated parts, and sub-assemblies, including dimensional checks, documentation review, material certifications, and NDT where applicable.
Maintain inspection records, nonconformance logs, and supplier scorecards, and drive corrective actions with suppliers.
Develop and maintain inspection documentation such as inspection plans, checklists, AQL/sample plans, and first-article inspection (FAI) procedures.
Own the response to customer compliance information requests, including quality plans, certificates of conformance, material traceability, weld documentation, and regulatory/standard questionnaires.
Review customer purchase orders, quality clauses, and specifications at order entry, translating them into internal requirements and communicating them to Engineering and Production.
Maintain a library of standard compliance responses and certifications to streamline customer onboarding.
Maintain and audit safety documentation (risk assessment records, hazard logs, compliance certifications) to support product liability defense and warranty/claims review.
Support customer-facing safety audits, insurance inspections, and machine safety certifications (e.g., UL, CE marking) as required by end markets.
Lead risk assessments per ANSI/PMMI B155.1 (Safety Requirements for Packaging and Processing Machinery) for new, modified, and rebuilt equipment, documenting hazard identification and risk reduction.
Partner with 3rd party OEM engineering during design reviews to identify foreseeable hazards and drive risk-reduction measures.
Investigate field incidents, near-misses, and customer safety complaints, driving corrective/preventive action and updating risk assessments.
Track evolving PMMI, OSHA, and CE/international machinery safety requirements and advise commercial and engineering teams on compliance impact for domestic and export orders.
Own and maintain the internal quality management system (ISO 9001 alignment preferred).
Lead root-cause analysis and corrective/preventive action (CAPA) for internal nonconformances and customer issues.
Support continuous improvement initiatives on the shop floor and in engineering processes.
Maintain the calibration system for inspection and test equipment.
Champion Filamatic’s safety programs and ensure equipment, supplies, and processes are regularly maintained.
Define, document, and enforce internal Factory Acceptance Test (FAT) standards and procedures, including test plans, acceptance criteria, documentation, and sign-off packages.
Lead or support FAT execution with customers on the shop floor, recording results, managing deviations, and ensuring customer acceptance.
Partner with Engineering and Assembly to resolve FAT findings before shipment.