Quality Assurance Engineer - Manufacturing

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.

Proficiency in quality tools: FMEA, 8D, 5-Why, cause/effect analysis, SPC, Gage

R&R, PPAP.

Excellent verbal and written communication skills with strong documentation discipline. Ability to multitask, manage priorities, and work independently or as part of a small team.

Education / Experience

Bachelor's degree in Mechanical Engineering, Industrial Engineering, Quality Engineering, or equivalent experience. Experience with ERP/MRP software. CMM or advanced metrology experience. Six Sigma or Quality Engineering certifications (CQE, CSSGB, etc.). Experience with process validation (IQ/OQ/PQ) and risk management tools. Schedule 8 hour shift Monday to

Friday 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