Senior Quality Engineer(R&D)

Job Overview

The Lead Engineer, Design Quality helps to supports the quality assurance efforts during the design and development phase of new products, ensuring compliance with industry standards, regulations, and customer requirements for the different projects in the Design and Engineering Services Group; from architecture to electronic circuit design and analysis, verification, validation and transfer into manufacturing.

Detail Description

• Provides engineering support and coordination around QMS. Understands Quality Management Systems for Design and Manufacturing.
• Support design reviews and design transfers providing inputs on quality and requirements.
• Guide and assist in developing Design Controls in compliance with 21 CFR 820, ISO 13485, ISO 9001.
• Develops and implements quality control procedures, work instructions, and inspection guidelines to enhance manufacturing and design processes.
• Provides engineering support and coordination for internal & external Design Audits.
• Helps to prepare submissions to FDA and CE Marking (EU MDR).
• Support the creation and updating of product risk management documents (Hazard analysis, DFMEA, RMP, RMR,…) in accordance with ISO 14971.
• Collaborates extensively with cross-functional teams, including design, manufacturing, supply chain, and customers, to address and resolve quality issues throughout the product lifecycle.
• Able to manage a single line engineering project with limited number of participants and create project / change management plan, establish and distribute project roles, being able to communicate what is needed from the project participants in order to make the project successful.
• Demonstrate "Individual Leadership Behaviors" as per Leadership Imperatives.
• The following competencies may also be required: Coaching/Mentoring; Communication/Negotiation/Presentation; Creative Problem Solving; Customer Interaction/Stakeholder Management; Quality & Lean; Working Effectively with Others; D/PFMEA; 8D/Corrective Action; Equipment Safety; Design of Experiments (DOE)

Knowledge/Skills/Competencies

• Expertise in root cause analysis, Failure Modes and Effect Analysis (FMEA), and 8D problem-solving methodologies.
• Familiarity with statistical process control (SPC) techniques and data analysis for quality improvement.
• Proficiency in the standards that need to be applied within the design and development process for the project under responsibility.
• Ability to develop and assess engineering processes.

Physical Demands

Duties of this position are performed in a normal office environment.

Duties may require extended periods of sitting and sustained visual concentration on a computer monitor or on numbers and other detailed data.

Repetitive manual movements (e.g., data entry, using a computer mouse, using a calculator, etc.) are frequently required.

Occasional travel may be required.

Typical Experience

Typically 1-2 years of progressive experience in Design Quality Engineering, demonstrating a clear track record of successful project contributions.

Typical Education

Bachelor's degree in Electrical Engineering, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical field.