Quality Engineer - Alameda, United States - DivIHN Integration, Inc

DivIHN Integration, Inc Alameda, United States

Found in: beBee S2 US - 2 weeks ago

OTHER

Description

*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:
$ $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

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