Quality Engineer
DivIHN (pronounced divine) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Rashi at
Title:
Quality Engineer
Location:
Alameda, CA
Duration:
12 Months with possible extension
Description:
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; knowledge of 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.
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and assessment of emerging regulations.
Recent experience with medical devices design controls; understanding of engineering change control process, familiarity with Agile PLM system
May require an advanced degree and 2-4 years of direct experience in the field.
Relies on analytical thinking and judgment to plan and accomplish goals.
Performs a variety of tasks. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
Please look for associates who have background not just in Regulatory Affairs but also from engineering, quality, and manufacturing, who are willing to look for a career in Regulatory Affairs.
Interviews:
1 interview with hiring manager and then interview with manager's leadership
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Estimated Salary: $20 to $28 per hour based on qualifications.
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