Quality Engineer II

Quality Engineer II

This role will work in the Quality Engineering team to support manufacturing and sustaining engineering activities. Must have experience in Quality, ideally with ownership of NCRs, CAPAs and oversight of changes to ensure conformity to applicable requirements (ISO 13485, FDA 21 CFR 820 and the QMSR).

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the client's systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Bachelor's degree in engineering required. 2-4 years' experience required.

Good computer skills in usage of MS Office Suite

Ability to read and interpret drawings

Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

Basic understanding of statistical techniques

Previous experience working with lab/industrial equipment required

Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering

Solid problem-solving, organizational, analytical and critical thinking skills

Solid understanding of processes and equipment used in assigned work

Knowledge of and adherence to Quality systems

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Must be able to work in a team environment, including the ability to manage vendors and project stakeholders

Ability to build productive internal/external working relationships

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control

Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes before final product release based on engineering principles; analyze results, make recommendations and develop reports.

Develop moderately complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.

Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.

Develop, update, and maintain technical content of risk management files

Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.

Assign support tasks; give instructions to technicians on conducting tests; train technicians and provide feedback; and may coordinate technician work.

Other incidental duties assigned by Leadership

At Talent Burst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

Talent Burst is an equal opportunity employer committed to an inclusive and diverse workforce.