Quality Assurance Manager

2 weeks ago


Telford, Pennsylvania, United States Draeger Safety , Inc. Full time
Job Summary

We are seeking a highly skilled Quality Assurance Manager to join our team at Draeger Safety, Inc. This individual will be responsible for managing supplier quality activities, developing and establishing supplier-related quality processes, and monitoring process performance and reporting on supplier KPIs.

Key Responsibilities

• Oversee and lead supplier quality assurance activities for the US site, including processes that support First Article Inspection, supplier monitoring and prioritization, auditing, supplier corrective action, and supplier quality improvement.
• Manage tasks and performance of employees, set and track objectives, assess performance on a regular basis, provide motivation, and create effective development and training plans.
• Develop and communicate Draeger Medical expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for high-leverage/critical sustaining parts and new products sourced to suppliers and contract manufacturers.
• Measure and communicate supplier performance on key metrics and the corresponding continuous improvement plans.
• Perform and coordinate supplier surveys, quality system and process control audits to applicable ISO standards. Support internal and external audits as they relate to Purchasing/SQA processes.
• Participate as an active member in the New Product development process, supplier evaluation team, and the sourcing core extended team. Ensure quality and regulatory requirements are implemented at key suppliers through FAI process, auditing, and contracting (QAA).
• Monitor and drive supplier corrective action process and continuous improvement activities that directly impact supplier performance.
• Willingness and flexibility for business travel both domestically and abroad, when required.

Requirements

• Bachelor's degree in engineering or other related technical field.
• 8 to 10 years in manufacturing/engineering/quality engineering experience with a minimum of 5 years in a leadership role for supplier quality.
• Project Management Skills:
• Working knowledge of medical device manufacturing strongly preferred.
• Knowledge of ISO 13485 and FDA regulations.
• Experience with statistical methods preferred.
• Experience with direct supervision of employees required.

Special Competencies or Certifications

• Strong written, verbal, analytical, negotiating, and interpersonal skills.
• Demonstrated success in solving quality problems.
• Ability to handle multiple tasks simultaneously.
• Demonstrated success in working with cross-organizational teams.
• Ability to organize and prioritize work to meet expected timelines.
• Process development knowledge.
• SAP Q-Module.
• ARAS.
• Process capability Analysis.
• Six Sigma/Lean manufacturing.

Work Environment/Conditions

Travel domestically and internationally as necessary (approximately 20%).

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