Career Opportunities
Position: Department: Location: |
Quality Assurance Engineer Quality Assurance Santa Barbara, CA |
Sientra is searching for a Quality Assurance Engineer to join our growing Quality Assurance team!
The Quality Assurance Engineer (QAE) is responsible for the implementation and maintenance of quality management systems related to design control, data analysis and risk management systems and programs, analyzing, identifying and implementing manufacturing and business process improvements to enhance the capability and performance of Sientra quality systems and the manufacturing and quality systems of contract manufacturers. The QAE is responsible for the analysis of quality and (primarily) contract manufacturing systems, trouble-shooting problems and providing input to ensure timely and effective corrections and corrective and preventive action as required. The QAE will analyze quality and manufacturing systems and processes in order to identify and mitigate possible sources of increased risk to product and processes; users and patients. The QAE will apply risk management techniques (FMEA, Fish-Bone, Histograms) and principles and provide follow-up in order to minimize, monitor and control the probability and impact of identified risks and events. The QAE will participate in design control and design change projects, maintaining design control and design history files and risk management files, and is responsible for ongoing integration of information inputs into those files and systems. The QAE will understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs, as well as applicable federal, state and local regulations.
Additional Duties and Responsibilities
- Provide accurate data input into Design Control, Risk Management, Complaint, CAPA, NCMR, and other Sientra documentation systems as required.
- Assist in internal audits as needed, working with internal staff and consultants.
- Provide assistance in compiling data for scheduled Management Reviews.
- Other duties as assigned
Qualifications
Education & Experience
- Minimum BS in an engineering discipline (Quality, Manufacturing, or Mechanical engineering), with an MS in biology, healthcare or business management preferred.
- Five (+) yrs. Experience working as an engineer in a medical device, medical product or pharmaceutical manufacturing environment.
- Experience working with international and U.S. regulatory bodies, such as Notified Bodies, Competent Authorities, FDA or EMEA.
- Understanding of plastic and reconstructive surgery, implants and related products preferred.
- Exceptional written and verbal communication skills.
- Experience interfacing successfully with operators, supervisors and managers and providing detailed and comprehensive analytics and reports at each and all levels of understanding.
If you would like to apply for this position, please email your resume to careers@sientra.com.