Senior Design Quality Engineer

Overview

This position will be responsible for concurrent quality engineering activities associated with product development and risk management. Primary responsibility will be to handle quality engineering duties throughout the development life cycle in the following areas: design controls, risk management, change control, post market review, quality planning, and establishment of appropriate requirements and traceability. The candidate will play an active role in the development processes to ensure products meet quality standards consistent with company policies

Responsibilities

This individual will be responsible for providing quality leadership, guidance and support in quality system methodologies for product development. This candidate will work directly with product development teams in support of the development of products within the multiple business units. The position requires the ability to handle multiple projects and tasks utilizing a high level of written and oral communication skills.

 

In this position, the candidate will be responsible for:

• Participating or leading in design and development planning; quality planning; supporting development of design requirements specification; Design History File management, design transfer activities, change management and design reviews;
• Developing risk management documentation;
• Supporting development of design verification and design validation documentation;
• Supporting test method development and validations;
• Ensures company policies, procedures, practices and facilities are in compliance with all applicable company policies and procedures;
• Lead/support internal investigations, implementing corrective and preventive actions;
• Serving as a quality representative on one or more project teams engaged in product development activities;
• Ensuring each project is developed and released meeting customer expectations, regulatory requirements including 21CFR820, ISO 13485, ISO 14971, MDD

 

 

Qualifications

• Bachelors Degree (B.S.) in chemistry, biology or related science/technical field, or related experience and a minimum of three (5) years or qualified related experience.
• Good understanding of chromatography and their applications.
• Strong working knowledge of development life cycle models.
• Broad experience in the application of design controls and risk management in an IVD or Device industry.
• Outstanding interpersonal and communication skills and ability to develop cross functional partnerships.
• Experience in the application of production and process controls including process validation, process control plans and statistical process control.
• Good understanding of relevant regulatory requirements (e.g. IVDD, MDD, FDA) and standards (e.g. ISO 13485, 14971). Previous experience of working in a quality system regulated environment to ISO 13485 and/or 21 CFR 820.
• Ability to work effectively in a team-oriented cross-functional environment and build strong working relationships.
• Ability to constructively challenge concerns and engage in transparent conversations.
• Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence.
• Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills).
• High degree of initiative and self motivation. Strong analytical skills and the ability to solve problems through analytical reasoning.