2 - 5 years of experience in manufacturing quality, with strong shop-floor presence
Ability to read engineering drawings and apply GD&T principles
Strong knowledge of quality systems including ISO 9001 and/or ISO 13485
Proficiency in quality tools: FMEA, 8D, 5-Why, SPC
Excellent verbal and written communication skills
Ability to multitask and work independently or as part of a small team
Responsibilities
Review engineering drawings and ensure flow-down to manufacturing
Develop and maintain Control Plans and Process Flow Diagrams
Establish sampling plans and inspection criteria using statistical tools
Identify process variations and lead improvement efforts
Conduct internal audits and support customer and supplier audits
Lead investigations for nonconformances and deviations
Support continuous improvement initiatives such as Lean and defect reduction
Benefits
Health Insurance (Medical/Dental/Vision) paid 100% for employees
Life insurance policy
Safe Harbor 401(K) plan
401(K) match
Paid time off (vacation/sick/holidays/floating holiday)
Referral Program
Full Job Description
Summary
The Quality Assurance Engineer (Manufacturing) supports the successful manufacture of products by developing and maintaining quality processes that ensure compliance with customer, regulatory, and internal requirements. This position plays a critical role in qualification of new and existing products, root-cause investigation, quality systems maintenance, supplier quality, and continuous improvement activities. The QA Engineer works closely with Production, Engineering, and Supply Chain to prevent defects, reduce scrap, and drive repeatable manufacturing processes.
Essential Duties and Responsibilities
Review engineering drawings, specifications, and customer requirements; ensure proper interpretation and flow-down to manufacturing and inspection.
Develop and maintain Control Plans, Process Flow Diagrams, PFMEAs, and Inspection/Test Methods for new and existing products.
Establish sampling plans, inspection criteria, and measurement methods using statistical tools (MSA, Gage R&R, capability studies).
Identify process variation and lead improvement efforts to increase capability and reduce defects. drawings and specifications.
Process Flow, FMEA & Product Quality Plan development and submission to customers.
Participate in maintenance and improvement of the QMS, including document control, risk management, nonconformance management, and CAPA.
Conduct internal audits and support customer, supplier, and certification audits.
Ensure quality records, inspection results, validations, and traceability documentation are complete and accurate.
Support change control activities, ensuring appropriate quality review and verification.
Lead investigations for internal and supplier nonconformances, customer issues, and process deviations.
Facilitate MRB meetings, document dispositions, and ensure timely closure of actions.
Use structured problem-solving (5-Why, Fishbone, 8D) to identify root cause and implement corrective and preventive actions.
Validate effectiveness of corrective actions and verify sustained improvement.
Audit and qualify new and existing suppliers, monitor supplier performance metrics.
Support Supply Chain and Engineering with supplier-related nonconformances, SCARs, and incoming inspection requirements.
Communicate quality expectations and provide feedback to suppliers to ensure ongoing compliance.
Assist in development and execution of IQ/OQ/PQ protocols for manufacturing processes and equipment.
Collect, analyze, and trend quality performance data including scrap, rework, nonconformances, returns/RMAs, and process capability.
Prepare quality reports and present findings to management along with recommended actions.
Support continuous improvement initiatives such as Lean, 5S, and defect reduction projects.
Collaborate with Engineering on manufacturability reviews, new product introductions, and drawing changes.
Support production floor activities including in-process checks, fixture/measurement development, and troubleshooting.
Perform other related tasks as assigned to support departmental and organizational goals.
Qualifications and Skills
2 - 5 years of experience in manufacturing quality, with strong shop-floor presence and practical problem-solving abilities.
Ability to read engineering drawings and apply GD&T principles.
Strong knowledge of quality systems and quality assurance concepts including ISO 9001 and/or ISO 13485.
