Overview
Skills
Job Details
We are seeking Medical Device Quality Engineering candidates to be considered for a Medical Device Quality Engineering position tha we have available in Irvine, CA. Knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and company systems / procedures to optimize product development, internal and external device manufacturing, and device distribution.
This role is W2 hourly with Roth Staffing (Ledgent is a division of Roth). No 3rd party candidates can be considered.
This team performs new product development for the quality group.
- Windchill PLM MUST have and be experienced
- Proficiency in Minitab is a plus!
MUST have fundamental principles of validation knowledge (i.e. test method validation versus process validation, etc.)
Statistical analysis experience (i.e. presented a data set or feasibility of a TMV, can they understand the data and any indications it shows). Must have technical writing experience
What does the ideal candidate need to possess to be successful in this role?
- Engineering sustaining work
- Ran small projects for commercial line manufacturing improvements
- Catheter & polymer experience a HUGE plus
Selling points:
- Opportunity to work on dev of next gen Tavar platform
- Learn state-of-the-art validation and statistical techniques
- Ability to interface with every and any type of team in medical device company
Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and company systems / procedures to optimize product development, internal and external device manufacturing, and device distribution.
Key Responsibilities:
* Investigate manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
* Conduct validation assessments for design / in-process inspection test methods and evaluate conformance to internal standards
* Identify opportunities for re-design / design of equipment, tools, fixtures, etc. to improve design test method / manufacturing inspection processes
* Support development of training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
* Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work
* Other incidental duties assigned by leadership
Education and Experience:
Bachelor's Degree in Engineering or Scientific field, 4 years related work experience required
or
Master's Degree or equivalent internship, senior projects or thesis experience in Engineering or Scientific field, plus 2 years related work experience required
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.