Quality Engineer II

Responsibilities

Develop and implement quality tests, establish acceptable result parameters, and define criteria for successful outcomes.

Create and update quality processes and system documentation to reflect ongoing improvements.

Perform scheduled internal audits, maintain audit records, and support audits conducted by other team members.

Initiate and manage updates to product specifications, including creating specifications for new products.

Serve as the administrator for the Statistical Process Control (SPC) system, ensuring optimal functionality and usage.

Analyze and report SPC data, collaborating with Engineering, Quality, and Production teams to enhance the system continuously.

Provide guidance and training to the Quality Inspector group on SPC data entry, interpretation, and programming tasks.

Conduct and support validation activities independently and in collaboration with Engineering.

Proactively support production launches, including first production lots, tooling, and material changes.

Deliver data analysis to support organizational Key Performance Indicators (KPIs).

Maintain and enhance QA Lab tools, equipment, and processes.

Lead and participate in customer and supplier audits, ensuring adherence to standards.

Investigate and support resolutions for customer complaints and internal failures.

Maintain and improve the Product Standard system to enhance defect tracking and decision-making on the shop floor.

Assist with the development and improvement of ERP system.

Manage data entry, control, and maintenance of testing logs and required reports, including processing and documenting Non-Conforming Material (NCM) dispositions.

Serve as a backup for other Quality team functions and responsibilities as needed.

Train and mentor QA team members, fostering skill development and knowledge sharing.

Plan, coordinate, and facilitate external audits to minimize issues and findings.



Requirements

Bachelor’s degree or equivalent work experience (preferred but not required).

3+ years of experience as a Quality Engineer in a production environment, preferably in Medical Device or flexible packaging.

Direct experience with customer interaction and communication.

Demonstrated expertise in root cause analysis and investigative techniques.

Hands-on experience with ERP/MRP systems.

Certification as a Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) is preferred.

Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).

Strong organizational skills and effective communication abilities, with the capacity to share knowledge and train others.