Quality Engineer

Quality Engineer

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.

What You Will Do (Responsibilities)

Incoming Inspection & Supplier Quality

• 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.

Customer & Supplier Quality Compliance

• 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

Product Safety

• 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 standards 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

Quality System & Continuous Improvement

• 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 Filamatics safety programs and ensure our equipment supplies and processes are regularly maintained.

Factory Acceptance Tests (FAT) Standards

• 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.

What You Will Bring (Requirements)

• Bachelors degree in Engineering (Electrical Mechanical Industrial Manufacturing Mechatronics) or equivalent experience OR an associates degree with significant relevant experience.
• 37 years of quality engineering experience inindustrial 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).
  • Customer compliance documentation and responding to customer quality questionnaires/specifications.
  • Hosting or supporting customer audits and source inspections.
  • 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.

Preferred / Nice-to-Have

• 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.

Compensation and Benefits

Salary Range: $85000 - $115000 per year

Benefits:3 weeks of annual vacation 10 paid holidays 401(k) with company contribution parental leave and comprehensive health (3 plan options) dental and vision coverage. Eligibility for insurance begins the first of the month following your first day of employment. Eligibility for 401(k) begins the first of the month following 60 days of employment.

About Us

Filamatic a division of National Instrument LLC has been a leading manufacturer of industrial packaging machinery for the Pharmaceutical Biotech Diagnostic Cosmetic and Cannabis industries for over 70 years. Our success is built on exceeding customer expectations creating a great working environment for our employees hiring exceptionally qualified staff and driving continuous process improvement.

Our Values represent the lens we use when making decisions that impact the company employees and our customers. Each person we add to our organization should reinforce these values. We seek out individuals who support/embrace these values.

Our Core Values: Adherence to the Golden Rule - Continuous Improvement - Customer Centric - Takes Ownership - Persistence - Courage to be Curious - Resilient Mindset - Practical Excellence.

To learn more about the exciting work of Filamatic please visit our website at check out our capabilities on our YouTube video: opportunities are contingent on successfully completing a background check drug test and physical as applicable based on the position.

Equal Opportunity Employer

National Instrument dba Filamatic is an equal opportunity employer. National Instrument dba Filamatic does not discriminate in employment with regard to actual or perceived race color creed religion national origin citizenship status ancestry age sex or gender(including pregnancy childbirth related medical conditions and lactation) gender identity or expression (including transgender status) sexual orientation marital status military service or veteran status disability protected medical condition as defined by applicable state or local law genetic information or any other characteristic protected by applicable federal state or local laws and ordinances.

Required Experience:

Senior IC