Sientra is a public company focused on serving the needs of medical professionals by developing, marketing and selling medical products.
Essential Duties and Responsibilities
The Quality Engineer is primarily responsible for assuring product and Quality Systems quality and compliance through the development, implementation and monitoring of appropriate processes, tools, metrics and goals. Specifically, the Quality Engineer position is the process owner for the site CAPA program, process validations, Customer Complaints, NCRs, CAPAs, Internal Audits, and assigned New Product Development programs.
Additional Duties and Responsibilities
Supports new product development activities as directed through core team participation in the development of Master Validation Plans, PFMEA's, Control Plans, Procedure and Process development
Supports investigation and resolution of NCRs and CAPAs.
Assist in other CAPA activities as directed, including complaint failure investigations and customer communications.
Owner of applicable Quality Systems related NCR/CAPA's.
Role is subject matter expert and technical advisor on the CAPA element of the site quality management system.
Maintains current knowledge of FDA QSR, ISO 13485 and Health Canada requirements and applies to applicable Sientra processes.
Analyzes inspection and testing processes, mechanisms and equipment.
Develops and/or reviews product, process test equipment and/or software validation and qualification protocols and tracks execution of protocols in support of project timelines.
Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
Observe and promote Company standards and policies on safety, quality and productivity.
Responsible for assisting/ performing necessary equipment/ process validations.
Responsible for ensuring all environmental and product monitoring requirements are met. Assures adequate sampling plans, inspection procedures and test methods are implemented.
Management review compliance
Creates and maintains quality indicators and respective reports/ presentations.
Responsible for the development and training of Quality employees.
Maintain an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies.
Evaluate, implement and continuously improve execution of Quality Systems and business processes, including product controls to achieve quality goals and maintain Regulatory Compliance.
Oversee the product release to ensure that safe and effective product is distributed to customers. Responsible for approval or rejection of components, finished products, and documents to achieve this purpose.
Other duties as assigned.
Requirements (Education, Certificates, Licenses, Registrations, etc.)
A minimum of a Bachelor's degree in science, engineering, other relevant discipline, or equivalent.
A minimum of 3 years of experience working in a FDA or ISO regulated environment or equivalent.
A minimum of 3 years of supervisory experience or equivalent.
Ability to analyze information and act on results
Ability to work well with people at all levels within the organization
Accuracy and attention to detail
This description contains the essential functions necessary to evaluate the position. It is not intended and should not be used as an exhaustive list of all responsibilities, skills or efforts.
FLSA Status: Exempt
If you would like to apply for this position, please email your resume to firstname.lastname@example.org.