Quality Engineer SE}

ARCH • Lower Moreland Township, PA

6d • Onsite

About The Position

The Quality Control Engineer facilitates workload schedule and priorities on a daily basis to ensure internal demands are met. Ensures no detectable defects are passed on to internal or external customers. Monitors the ongoing effectiveness and improvement of the Quality Management System and proliferates a culture of Quality throughout the organization. The Quality Control Engineer provides subject matter expertise to Quality Control Inspectors and the shop floor.

Requirements

• Thorough knowledge and understanding of inspection methodology and sampling
• Thorough knowledge and understanding of quality philosophies, principles, methods, and tools
• Knowledge and understanding of ISO 13485 and 21 CFR Part 820
• Proficient with Microsoft Office applications, including Word, Excel, and PowerPoint
• Ability to communicate extremely well across all levels and departments of a business
• Strong interpersonal skills
• Self-motivated with high degree of accountability
• At least five years of work experience with an ISO1345 certified and FDA regulated environment
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to effectively present information to top management.
• Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.
• Ability to deal with problems involving a few concrete variables in standardized situations.

Nice To Haves

• Certified Quality Inspector (CQI) or equivalent certification preferred

Responsibilities

• Use data related to the QC process to effectively manage the QC operation and communicate to internal customers, including QC throughput and prioritization
• Perform QC Inspections on an as needed basis
• Ensure functionality and optimization of CMM, Sylvac and/or CT Scan operations and programming
• Enforce compliance to relevant internal procedures throughout the QC group
• Participate in customer and regulatory audits, as required
• Identify and control nonconforming material and provide all related details during Material Review Board meetings in a timely manner
• Provide quality expertise and guidance during daily operations meeting
• Provide programming and operational support to CT scanning processes as needed/appropriate
• Actively provide guidance related to quality control

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed