Sr. Quality Engineer
This Sr. Quality Assurance Engineer will develop, coordinate and implement various activities pertaining to the effective management of the quality management system (QMS).
- Assures medical devices are designed and developed in accordance with 21 CFR Part 820, ISO 13485, and other applicable standards/regulations
- Member of design and development s and performs quality engineering related tasks. Examples of task include:
- Participate in the creation and execution of functional/design requirements
- Support risk management activities including creation of plans, reports, and FMEAs
- Support and approve design verification/validation activities
- Assist in the application of statistical methods
- Participate in design reviews
- Assure cascading of critical to quality features throughout design transfer
- Assures device design is correctly transferred to contract manufacturers
- Audits contract manufacturers and suppliers
- Manages product nonconformance process and is member of Material Review Board (MRB) responsible for the investigation, corrective action, and dispositioning of product nonconformances
- Member of Change Control Board (CCB) responsible for conducting design and documents change impact assessments
- Responsible for customer complaint investigations and recommending corrective actions
- Assures acceptance activities (receiving, in-process, final) are properly defined and executed.
- Compiles data/reports for input to Management Reviews
- Assists VP Quality & Operations in the management of corrective & preventive actions (CAPA) process
- Participates in FDA inspections and ISO 13485 assessments
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of integrity, ethics and compliance at all times.
- Additional duties as assigned.
- 5 years of experience in a related industry or regulated environment (e.g., ISO 13485, 21 CFR Part 820) in one of the following functions: Quality Control, Manufacturing, and Product Development.
- Associates degree (or higher) related to life sciences or equivalent