Seeking an experienced Quality Engineer with the desire to further you career with one of the largest medical device companies in the country. The primary responsibility of this position is to identify, monitor and improve quality metrics and processes in support of the quality goals.
location: Carlsbad, California
job type: Permanent
salary: $100,000 - 105,000 per year
work hours: 9 to 5
- Ensure adherence to Quality System requirements in an FDA and ISO regulated environment throughout product and process lifecycles. This includes products in design and development as well as products in production and the processes which support them.
- Perform investigations and root-cause analysis activities as they related to Corrective/Preventative Actions (CAPA), and drive continuous improvement.
- Perform analysis, trending and reporting of inspection and test data to insure conformance to specifications.
- Perform design and process validation studies in conjunction with R&D, Engineering and Manufacturing to ensure compliance to applicable standards. Ensure validation and revalidation of production cells by evaluating equipment and processes for critical and non-critical parameters, performing capability studies and integrating findings into validation protocols.
- Ensure compliance in manufacturing areas and escalate nonconforming situations. Initiate and lead root cause investigations and documentation for non-conformities. Review dispositions of non-conformities for compliance and presence of objective evidence.
- Perform in-house failure and complaint investigations to determine deficiencies in product design and manufacturing processes.
- BS or BA in Engineering or Life Sciences
- Minimum of 7 years in the medical products industry
- Familiarity with QSR (FDA) & ISO Standards, Design and Process Validation Experience
- ASQ QE Certification desirable
- May be required to supervise technician or inspector on a project basis.
- Daily interface with Research and Development, Engineering, Quality Control, Regulatory Affairs, Manufacturing, Manufacturing Engineering, Technical Service on project and product issues.
- Occasional interfacing with distributors for purposes of resolving product problems.
skills: Quality control, SOP, FDA, Quality Assurance, Regulatory Affairs Operations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.