Sr. Quality Assurance Engineer

The purpose of the Sr. Quality Assurance Engineer is to execute various quality activities per client established quality management system (QMS) and risk management tools and in accordance with 21 CFR Part 820, ISO 13485, EU MDR 2017/745, customer requirements, and applicable standards and regulations. This role supports the client's medical device product development team.

Member of design and development teams 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.
Assures acceptance activities (receiving, in-process, final) are properly defined and executed.
Compiles data/reports for input to Management Reviews.
Assists QA Associate Director Devices in the management of corrective & preventive actions (CAPA)
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.

Skills:
Min 7 years in medical device quality assurance, manufacturing, or product development
Medical device experience required
Knowledge of 21 CFR Part 820, ISO 13485, and Medical Device Regulation
Excellent customer service focus and professionalism
Proven track record of leading and managing quality or manufacturing initiatives in medical device and supplier relationships with component or contract manufacturers.
Excellent interpersonal skills with proven ability to get along well with others and work in a team environment.
Excellent verbal and written communication skills

Education
Bachelor's preferred