Quality Engineer - Plastic Injection Molding

PREFERRED CANDIDATE PROFILEnice to have

• 3+ years of experience in medical device manufacturing, preferably in injection molding environments
• Deep knowledge of measurement systems, metrology, and capability studies, including CMM programming and advanced gage usage
• Proven experience designing and executing validation protocols (IQ/OQ/PQ)
• Demonstrated ability to present technical findings and quality results to external customers and internal stakeholders
• Strong problem-solving skills with experience in root cause analysis and failure investigations (e.g., 5 Whys, Fishbone, FMEA)
• Comfortable working in cross-functional teams and regulated environments (ISO 13485, 21 CFR 820)

• Execute principles and practices of metrology and measurement, in designing measurement methods/system in NPI into manufacturing and quality control to ensure that products meet design specifications, customer specifications and industry standards through creation of quality planning.
• Analyze process and product data, identify quality issues, and drive systemic improvements, which can involve conducting process capability studies
• Evaluating production processes to ensure they can meet customer requirements and specifications.
• Utilizing statistical methods, like Statistical Process Control (SPC), to analyze data and determine if a process is stable and capable.
• Driving process improvements to reduce variation and enhance product quality.
• Key partner with Operations for designing, executing, and documenting validation activities for equipment, processes, and systems within work cell(s), and write validation reports (IQ/OQ/PQ) for equipment and processes.
• Assisting with monitoring and maintaining the Quality Management System (QMS) to ensure compliance with ISO 13485 and 21 CFR part 820 (Quality System Regulation).
• Providing focused, Quality Engineering support via communication to department managers of the Quality Management System including Complaint, CAPA, Risk Management, Supplier Quality and Document Control processes.
• Investigate and resolve quality issues (CAPA/Complaints/NCMRs) to meet site procedures, FDA requirements as well as ISO-13485 and AS9100 requirements.
• Perform and support Quality Inspection and Documentation control Specialist duties as needed.

• Review new customers orders and specification to identify any changes to existing specification or note new specification and initiate and implement change control under Contract Review.
• Ensuring assignment, processing and execution of identified changes are approved on time (within 2 business days)
• Extremely adapt and super-user of eQMS in relation to document controls, NCMR and CAPA processes.
• Investigate and resolve quality issues through formal root cause analysis and failure investigation techniques, including CAPA, complaints, and NCMRs
• Present quality and validation results clearly and confidently in both internal team settings and external customer audits or meetings.
• Develop and evaluate calibration systems, perform routine maintenance and troubleshooting of measurement equipment, and analyze data to ensure accuracy and consistency. Perform CMM operation and programming
• Ensure Quality Management System documentation and reporting of all Quality-related issues and projects are maintained.
• Identify and support the Quality Manager by executing plans and actions to achieve assigned quality goals.
• Coordinate the tracking and closure of Quality issue-related documentation and Change Control related to RMA, NC, CAPA, and MRB System.
• Support process owners and department managers/value stream leaders in methods of process improvement and process control related to RMA, NC, CAPA, and other Quality Management issues or concerns.
• Monitor customer requests and ensure successful execution of customer-driven acceptance activities.
• Develop, vet, and maintain inspection plans.
• Measure components utilizing advanced measuring equipment (i.e., CMM, vision systems, etc.) and various hand gages such as calipers and micrometers. 

Benefits Include

• Professional Development/On the Job Training

• Health and Wellness Benefits

• Clean, Friendly, Safe work Environment

• Recognition and Rewards Program

• Tuition Re-imbursement

• Competitive Pay/Merit Increases

• 401k w/ Company Match

• Employee Assistance Program (EAP)