MGR II Quality & Reliability Engineer

Job Overview

TE Connectivity’s Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication.

What your background should look like:

The Quality Manager has complete site responsibility for Quality at our Wilsonville, OR location: 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, regulatory agencies, customer and internal audits.

Manages and provides resources for new product development, quality engineering, inspection, measurement, and test, complaint handling, non-conforming product and MRB resolution.

Ensures compliance to FDA QSR, ISO, MDD and other applicable requirements.

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.

Contributes with the strategic Site team effort to accomplish results as needed

Provides leadership in the continuing evolution, improvement, and efficiency of the quality function.

Develops quality personnel to assure continuity and personal growth.

Understands and complies with all company rules and regulations.

Builds a Safe and Inclusive environment

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.

Leadership skills

Technical discipline or quality professional training.

Statistical techniques, metrology, and process analysis training.

Quality system design and implementation experience.

Lead and supportive on external audits.

Risk management.

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.

Experience with MS Word, Excel, Project Management and Analytics software

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