Associate Quality Engineer

  The Associate Quality Engineer is an entry-level opportunity for an engineering professional looking to build a career in Quality Engineering within a manufacturing environment. This role provides hands-on exposure to quality systems, process validation, root cause analysis, CAPA, continuous improvement, and manufacturing processes while working alongside experienced Quality, Engineering, and Production team members. Recent engineering graduates are encouraged to apply!   KEY ACCOUNTABILITIES: (The broad spectrum of items that the role is ultimately held accountable for at the end of the day. Results.)   Assigned quality tasks completed accurately, on time, and supported by complete objective evidence. Assigned NCR, MRB, CAPA, SCAR, RMA, and complaint actions advanced to closure within required timelines, with risks escalated promptly. Quality planning and inspection documents kept current and aligned with the released process, tooling, and customer requirements. Validation and PPAP deliverables prepared to procedure and ready for review and approval. Measurable progress toward independent Quality Engineer competency through the assigned training and development plan.   KEY RESPONSIBILITIES: (The finer details of what the role is assigned for the day-to-day activities on the job. Tasks to support results.)   Apply ISO 13485/ISO 9001 QMS procedures, customer requirements, and applicable regulatory requirements, including FDA QMSR where relevant, to all assigned work; follow good documentation practices. Support quality deliverables for assigned programs through Seaway’s Stage-Gate process; review drawings, specifications, GD&T, and critical-to-quality characteristics with senior team members. Assist with APQP, first article inspection, and PPAP preparation, including process flow diagrams, PFMEAs, control plans, dimensional results, and material certifications. Draft and execute IQ/OQ/PQ protocols and reports under the direction of a senior Quality Engineer; collect and analyze data, document deviations, and compile reports for approval. Maintain alignment among PFMEAs, control plans, inspection instructions, and work instructions; update documents through change control and gather evidence for tooling, resin, equipment, and process change evaluations. Perform measurement system analysis (Gage R&R), SPC, and capability studies on assigned processes; build working knowledge of design of experiments. Support inspection methods, sampling plans, and metrology, including dimensional layouts, first-piece approvals, and gauge selection; verify calibration status of equipment used for acceptance. Investigate and document nonconforming material through NCR and MRB; assess risk, recommend disposition for authorized approval, and track actions to closure. Support customer complaints, RMAs, CAPAs, and SCARs through containment, data collection, root-cause analysis (5 Why, fishbone, 8D), corrective action, and effectiveness verification. Participate in internal, customer, supplier, and ISO 13485 audits through preparation, evidence retrieval, and follow-up of assigned actions. Trend scrap, rework, defects, and complaints; support Lean/Six Sigma projects that reduce defects and cost of poor quality, using DMAIC, A3, and 8D methods. Respond to quality issues on the production floor; reinforce adherence to procedures, work instructions, and acceptance criteria with Production, Processing, and Inspection teams. Complete the assigned training plan and build competency in quality engineering tools, molding and assembly processes, and regulatory requirements through hands-on work and mentorship.   LMA RESPONSIBILITIES: (Leadership, Management, Accountability)   No direct reports. Accountable for the quality and timeliness of own work and for escalating product, process, and compliance risks to the Quality Engineer or Quality Manager. May guide inspectors and technicians on documented methods within assigned scope.   QUALITIES FOR SUCCESS: (Seaway Core Values, Education, Training, Certifications, Years of experience, Other skills and abilities, Physical Requirements for the Role, etc.)   Demonstrates Seaway Plastics Core Values We are customer focused We execute We win together We are respectful   Required Bachelor’s degree in mechanical, manufacturing, industrial, biomedical, plastics, or materials engineering, or a related technical discipline. Recent graduates are encouraged to apply. 0–2 years of experience in quality, engineering, or manufacturing; internships, co-ops, and relevant academic projects are considered. Ability to read and interpret engineering drawings and specifications, with a working understanding of GD&T. Basic knowledge of statistics, root-cause analysis, and structured problem solving. Strong analytical skills, attention to detail, and the ability to manage multiple assignments to deadline. Clear written and verbal communication; effective in cross-functional teams; proficient in Excel, Word, and PowerPoint.   Preferred Exposure to injection molding, assembly, or plastics processing. Exposure to ISO 13485, FDA QMSR, cGMP, or other regulated manufacturing requirements. Exposure to IQ/OQ/PQ, PPAP, FMEA, or control plans. Six Sigma Yellow Belt or Green Belt training; ASQ CQIA or progress toward CQE. Hands-on use of calipers, micrometers, height gauges, CMM, or vision measurement systems. Experience with Minitab or similar statistical software and ERP systems such as Epicor. Familiarity with documents, change, and revision control.   Work Environment Regular work on the production floor and in controlled or cleanroom environments, following gowning, PPE, and safety requirements. Ability to stand and walk for extended periods and handle parts, gauges, and fixtures.   Physical Demands Sit, stand, and walk throughout office and manufacturing environments. Use computers and quality inspection equipment for extended periods. Perform visual inspections with strong attention to detail. Occasionally bend, reach, and lift up to 25 lbs. Communicate effectively with cross-functional teams and production personnel.