Location: Santa Clara, CA
Description:
- We are seeking an experienced, high caliber Quality Engineer II to be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.
- Each employee can make a difference at Client and has the power, either individually or as a team, to influence the success of the company.
- We are team-oriented, fast-paced and progressive.
- We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
- This role is an individual contributor position, requiring the candidate to have comprehensive knowledge in the specific area.
Qualifications:
- BS degree in Engineering or Technical Field or equivalent experience; 2-5 years’ experience.
- Engineering experience and demonstrated use of Quality tools/methodologies.
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
- Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Advanced computer skills, including statistical/data analysis and report writing skills.
- Experience implementing various product and process improvement methodologies (e.g.,
- Six Sigma and Lean Manufacturing).
Top Skills:
Fair level of engineering knowledge in Biomedical or Manufacturing space Attention to detail Accommodate fast changing priority, multi-task Non-conforming Report QPI Writing.
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.