Manager II, Quality & Reliability Engineering

Job Overview

The Quality Manager has complete site responsibility for Quality: ensuring that processes are suitably designed and implemented to maintain a continually effective and complaint quality system; representing the organization to external parties regarding the QMS (e.g., customer, assessor, FDA & other regulatory entities); leading quality improvement initiatives in support of customer and TE Connectivity Medical Business Unit objectives; allocating resources quickly and effectively to support business needs; providing exceptional service to the business unit to assure the shipment of quality products on time; making timely decisions to mitigate risk and assure rapid issue resolution.

Responsibilities:

• Manages plant quality staff across quality systems and product quality.
• Oversees the quality and documentation system and quality records program.
• Manages QMS processes for management review, CAPA, and internal audit.
• Manages and provides resources for quality engineering, supplier quality, inspection, measurement, and test, complaint handling, non-conforming product and MRB resolution.
• Ensures procedural compliance to FDA QSR, ISO, MDD and other applicable requirements.
• Acts as site Management Representative for the TEM quality system.
• Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis, statistical methods and process controls.
• Provides sales and marketing support in explaining quality system and regulatory compliance capability to customers.
• Provides leadership in the continuing evolution, improvement, and efficiency of the quality function.
• Teaches, trains, and develops quality personnel to assure continuity and personal growth.
• Understands and complies with all company rules and regulations.
• Reports unsafe conditions and practices to management.
• Immediately reports injuries to management.
   

What your background should look like:

• 10 years or more in a quality function with 5 years or more in management position.
• BS/BA degree with a scientific/engineering emphasis required.
• Technical discipline or quality professional training.
• Statistical techniques, metrology, and process analysis training.
• Quality system design and implementation experience.
• Risk management training.
• Regulatory requirements and reporting responsibilities.
• Supply chain development and management.
• Strong analytical skills and attention to detail.
• Excellent interpersonal and written communication skills.
• Demonstrated ability to effectively organize, prioritize and accomplish multiple tasks, make decision and solve problems independently.
• A thorough knowledge of 21 CFR and ISO 13485.
• Commitment to ethical conduct and responsibility.
   

Competencies