Quality Engineer

Key Responsibilities

• Validation & Qualification: Lead the authoring and execution of validation protocols (IQ, OQ, PQ) for new tooling, injection molding machines, and automated assembly equipment.
• Regulatory Compliance: Maintain the Quality Management System (QMS), ensuring all processes align with ISO 13485:2016 and FDA 21 CFR 820.
• Risk Management: Conduct and update PFMEAs and risk assessments to identify and mitigate potential manufacturing defects such as splay, flash, or short shots.
• Process Control: Apply Statistical Process Control (SPC) and Scientific Injection Molding principles to monitor production stability and perform Gage R&R or capability studies.
• Continuous Improvement (CAPA): Lead root cause investigations for NCMRs and CAPAs using advanced problem-solving tools like 5-Whys, Fishbone, and Minitab for data analysis.
• Metrology Oversight: Define inspection plans and verify part accuracy using GD&T callouts with CMM or vision systems.

Essential Job Functions:

• Create visual aids and Quality Alerts.
• Create Quality Control Documentation
• Perform Gage Reproducibility and Repeatability (Gage R&R)
• Support QC inspectors when necessary
• Assure PFMEA Risk Assessment and Mitigation processes are performed and completed as part of the Product Realization process.
• Assist in the development of control/inspection/sampling plans for new products that meet customer and/or PFMEA requirements.
• Create and Conduct APQP, PPAP, or other Product Qualification processes, as determined by customer requirements.
• Review/prepare test plans and reports (qualification, validation) for assigned activities. 
• Support ISO and customer QMS audits
• Support the maintenance and continuous improvement of the QMS
• Lead all non-conformance and MRB activities
• Lead or participate in Corrective and Preventive Action activities
• Performs any First Article Inspections (FAI) with QA personnel

Required Experience, Knowledge, Skills and Abilities:

• Bachelor’s Degree in Mechanical Engineering, Plastics Engineering, or a related scientific field
• 3-5 years in a regulated medical device manufacturing environment, specifically focused on plastic injection molding
• Experience in interpreting GD&T callouts
• Proficient in metrology hand tools (calipers, micrometers, etc.)
• Understanding of ISO9001:2015 and ISO13485:2016 requirements
• Knowledge of IQ/OQ/PQ process requirements.
• Basic problem-solving tools (5-why, 8D, CAPA, etc.)
• Auditing experience

Preferred Qualifications & Skills:

• Experience with plastic injection molding
• ASQ CQE certification
•  Six Sigma
• IQMS
• Proficiency in SolidWorks or Fusion360
• Minitab
• CMM (PC-DMIS)
• Vision CMM (Micro-Vu-InSpec software)
• Calibration

Work Environment/Physical Requirements:

• Split Environment: Time is divided between a standard office setting for data analysis and reporting, and the manufacturing floor for process audits and troubleshooting.
• Cleanroom Access: Frequent entry into ISO Class 7 or 8 cleanrooms, requiring strict adherence to gowning protocols (hairnets, gloves, lab coats) to prevent contamination of medical components.
• Ability to stand for long periods of time.
• Able to push, pull, lift, and carry up to 50 pounds.
• Standing, walking, bending, reaching, kneeling.
• Possibility of exposure to noise, uncontrolled temperatures, and chemicals.