Quality Engineer II

Skills:

Top Requirements:

1.Medical device experience- hands on experience working on the floor with inspectors and operators

2.Non-conformance investigation

3.Product evaluation

4.Analysis of quality metrics

5.Documentation- updates and creation

Duties:

Applies knowledge of technical principles and Client systems/procedures to optimize manufacturing processes.

Job Functions

• Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills

• Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports

• Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)

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

• Establish project plans to ensure deliverables are completed to customers expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)

• Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work

• Other incidental duties assigned by Leadership

Level of Independence

• Works independently without close supervision

• Compares and evaluates possible courses of action after considering various possibilities

• Applies his or her knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met

• Considers the cause and effect of activities

• Determines or effectively recommends course of action after considering potential risks of alternatives

• May provide guidance to lower level personnel

• Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment

• Direction tends to be high level and focused on end results with means of accomplishment left to incumbent

• Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)

• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

• Basic understanding of statistical techniques

• Previous experience working with lab/industrial equipment required (if applicable)

• 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 Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

• Knowledge of applicable FDA regulations for medical device industry

• 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 EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education:

Bachelor's Degree in Engineering or Scientific field with 2 (min) Years of Experience OR Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education.