Quality Engineer

Filamatic•Baltimore, MD

11d•$85,000 - $115,000•Onsite

About The Position

For over 70 years, Filamatic has been a trusted name in industrial packaging machinery, serving the Pharmaceutical, Biotech, Diagnostic, and Cannabis industries. As a division of National Instrument, LLC, we design, build, test, and ship custom and standard machines that our customers depend on every day. We are a smaller OEM where quality is not a department - it is a culture. Our Quality Engineer wears many hats, owning quality from the moment a component arrives at our dock through to the Factory Acceptance Test (FAT) and final customer sign-off. If you are an engineer who thrives on variety, direct impact, and high ownership, this is the role for you. The Quality Engineer is the owner of our quality management system and the day-to-day quality voice across the shop floor, engineering, and customer-facing activities. You will lead incoming inspections, manage customer compliance and information requests, support and host customer audits, and set and hold the standards for internal Factory Acceptance Tests (FATs). You will work closely with Engineering, Procurement, and Assembly to ensure every machine we ship complies with drawing, BOM, contract, and customer requirements and standards. This is a hands-on, high-ownership role with real visibility and direct impact on the products we deliver.

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 with: Hosting or supporting customer audits and source inspections.
Hands-on experience with: 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 — this role interacts directly with customers, suppliers, and internal teams.
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 (dimensional, documentation, material certs, NDT where applicable).
Maintain inspection records, nonconformance logs, and supplier scorecards; drive corrective actions with suppliers.
Develop and maintain inspection documentation: 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; translate them into internal requirements and communicate 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 per the standard’s formal methodology
Partner with 3rd party OEM (integration, mechanical, electrical, and controls) engineering during design reviews to identify foreseeable hazards and drive risk-reduction measures to an acceptable/tolerable level before machines ship
Investigate field incidents, near-misses, and customer safety complaints; drive corrective/preventive action and update risk assessments accordingly
Track evolving PMMI, OSHA, and CE/international machinery safety requirements; 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; experience with ISO 9001 implementation/maintenance a plus).
Lead root-cause analysis and corrective/preventive action (CAPA) for internal nonconformances and customer issues (8D, 5-Why, fishbone, etc.).
Support continuous improvement initiatives on the shop floor and in engineering processes.
Maintain calibration system for inspection and test equipment.
Champion Filamatic’s safety programs and ensure our equipment, supplies, and processes are regularly maintained.
Define, document, and enforce internal FAT standards and procedures — test plans, acceptance criteria, documentation, and sign-off packages.
Lead or support FAT execution with customers on the shop floor; record results, manage deviations, and ensure customer acceptance.
Partner with Engineering and Assembly to resolve FAT findings before shipment.