Quality Engineer
Cypress HCM
San Diego, CA
- Expired: over a month ago. Applications are no longer accepted.
Job Description
Quality Engineer – Med Device
We are looking for a talented Quality Engineer for an exciting Medical Device Company. This is key position within the Quality Department to ensure compliance with regulations.
Responsibilities:
- Develop project Quality Plans to enable new product implementation or changes to release product to meet regulatory requirements
- Actively identify process improvements and drive implementation of changes
- Review Product Development deliverables to ensure they are completed accurately and efficiently
- Support post market product monitoring, and generate metrics for the teams
- Develop and maintain QA procedures and forms
- Develop and lead training for QA systems, create/ schedule/ conduct/ track yearly training and update the system.
- Support the completion of risk assessment, as related to QA systems
- Perform incoming inspection/ field investigations
- Manage or support the response to audit findings and CAPAs
- Review equipment qualifications (Installation, Operational, Performance)
Requirements:
- Bachelor’s degree in engineering or science (Mechanical or Biomedical Engineer preferred)
- Experience with medical device quality compliance requirements including ISO 13485, ISO 14971 and FDA 21 CFR Part 820
- Knowledge of quality systems including Six Sigma, SPC, sampling plans, process mapping, inspection and testing
- Excellent communication skills to effectively provide written and verbal communication to supporting teams
- Ability to effectively write reports, work instructions, and procedures
- Proven ability to interpret quality and regulatory
- Leadership and flexibility to work with the business to address quality risks and improvements
- Internal audit certification preferred
Salary Expectations:
- $100-135K
Cypress HCM
Address
San Diego, CA
USA
Industry
Manufacturing
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