Title: Senior Manager Quality Engineer
Salary: $150,000-$180,000
Company Summary: The Senior Manager, Quality Engineering will oversee making sure that goods fulfill industry standards and the highest quality requirements, as well as any applicable laws and regulations. In addition to training the members of the Quality Engineering team and cultivating a compliance culture inside the organization, the Senior Manager is crucial in guaranteeing the efficacy, safety, and dependability of the company's product line. As this is a hybrid role, applicants must live close enough to our Carlsbad location to commute.
The Senior Manager Quality Engineer will be responsible for:
* Oversees the work of a group of competent engineers and technicians, offering them direction, instruction, and assistance to guarantee their performance and professional growth.
* Supervises protocol and report development as well as testing and validation procedures as needed to guarantee adherence to quality standards.
* Oversees management of the sterilization program which includes validations and monitoring environmental controls
* Uses of the proper statistical techniques, including data collection and summarization, confident conclusion-making, sample size determination, application of statistical process controls (SPC), relationship-finding, and statistical decision-making.
* Creates and verifies test procedures while utilizing metrology techniques for calibration systems, traceability, measurement error, and device and standard control. Performs measurement system error investigations, such as Gage R&R
The Senior Manager Quality Engineer should have the following qualifications:
* Minimum of 10 years' experience in quality engineering for medical devices
* Five years or more of experience in direct employee management
* Comprehensive knowledge of industry standards, regulatory regulations, and quality management systems that are unique to the medical device sector, including a working familiarity with ISO 14971:2019, ISO 13485:2016, and 21 CFR 820.
* Significant experience in statistical data analysis and root cause analysis
* Sterilization and packaging validation experience
Benefits:
* Medical Insurance
* Dental Insurance
* Vision Insurance
* Employer-Paid Basic Life Insurance
* Supplemental Life Insurance
* Employer-Paid Short-Term Disability
* Long-Term Disability
* 401(k) Plan
* Paid Time Off
If you are interested in the Senior Manager Quality Engineer role, then please don't wait to apply. If you have any questions feel free to reach me at adamtizabi@gmail.com.
