Quality Engineer

*Title: Quality Engineer*
Location: Alameda, CA
Duration: 12 Months with possible extension

*A detailed description of the position will be shared once we get your application*

*Quality Engineer*

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
* Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
* Review/approval of engineering study protocols/reports and validation study protocols/reports.
* Review and approval of manufacturing changes for Class III implantable medical devices.
* May require an advanced degree and 5-8 years of direct experience in the field.
* Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements
* FDA PMA guidance documents and CFR regulations.
* Relies on extensive experience and judgment to plan and accomplish goals.
* Performs a variety of tasks.
* May lead and direct the work of others. A wide degree of creativity and latitude is expected.
* Typically reports to a manager or head of a unit/department.
* Emerging Regulations team- manages regulations and works with cross function teams.
* Regulations can be very narrow and specific. Analytical, proactive, communication skills, must do research and prep work to understand regulations before meetings with stakeholders.
* Some documentation work - identify gaps in processes or product design.

Job Type: Contract

Pay: $44.00 - $47.00 per hour

Benefits:
* Dental insurance
* Health insurance
* Life insurance
* Referral program
Schedule:
* Monday to Friday

Application Question(s):
* Do you have regulatory affairs/ Quality Engineer experience?
* Do you have medical device experience?

Work Location: In person