Job Summary The Quality Engineer is responsible for ensuring that all products and processes meet internal, customer, and regulatory quality requirements through statistical analysis, process validation, risk management, and continuous improvement initiatives. This role supports production, engineering, and customer-facing activities, with a strong focus on injection molding processes, critical-to-quality (CTQ) characteristics, and regulatory compliance under

ISO 13485

2016 and AS9100 Rev D. The Quality Engineer reports directly to the Quality Manager and acts as a technical leader in quality assurance and process control across both medical and aerospace product lines. Responsibilities Ensure product conformity to customer drawings, specifications, and regulatory requirements. Lead and execute First Article Inspections (FAI), FAIR (AS9102), PPAP, and PAPP submissions. Develop, implement, and maintain Control Plans aligned with PFMEA outputs. Monitor, analyze, and improve critical-to-quality (CTQ) dimensions and characteristics. Review and disposition non-conforming material (NCMR/MRB) and lead containment activities. Perform Process Capability Analysis (Cp, Cpk, Pp, Ppk) using Minitab or equivalent. Implement and interpret Statistical Process Control (SPC), including X-bar/R, Individuals/MR, and attribute control charts. Lead and execute IQ, OQ, and PQ validation protocols and reports. Design, conduct, and analyze Design of Experiments (DOE) for process optimization. Perform and qualify Gage R&R and Measurement System Analysis (MSA) studies. Develop histograms and trend analyses to support data-driven decision making. Develop and maintain PFMEA documentation, including RPN scoring and mitigation strategies. Lead Root Cause Analysis using 6M / Ishikawa, 5 Why, and Fault Tree Analysis. Implement and verify the effectiveness of Corrective and Preventive Actions (CAPA). Drive scrap reduction, yield improvement, and cost-of-quality (COQ) initiatives. Champion lean and Six Sigma improvement projects within the value stream. Provide technical support for injection molding process validation, scientific molding, and optimization. Support mold qualification, troubleshooting, and process window development. Analyze molding defects including flash, sink, warpage, knit lines, short shots, burn marks, and contamination. Collaborate with the Toolroom on tooling condition, wear analysis, and preventive maintenance strategies for critical components. Support material qualification, lot traceability, and resin/colorant change controls. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to stand; walk and talk or hear. The employee is frequently required to sit; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Language Skills Ability to read, analyze and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports, correspondence and procedures. Ability to effectively present information and respond to questions from groups or managers clients, customers or employees of organization. Required Education and Experience 1. Bachelor's degree in Engineering (or Associate's Engineering degree plus minimum 4 years of industrial experience) or related technical field. 2. Minimum of 3 years of related experience. 3. Supervisory/management experience. Preferred Education and Experience 1. Bachelors degree in mechanical engineering, manufacturing engineering or industrial engineering 2. ASQ Certification 3. Lean/Six-sigma Certification 4. Lead Auditor certification (ISO 13485 / AS9100)

Other Duties Pay:

$80,000.00 - $85,000.00 per year

Benefits:

401(k) Dental insurance Flexible spending account Health insurance Life insurance Paid time off Retirement plan Tuition reimbursement Vision insurance

Work Location:

In person