Quality Engineer (Regulatory) at Kyyba

Job Title                     : Quality Engineer (Regulatory)

Location                      : Alameda, CA 94502

Contract Duration      : 12+ Months Contract with possibility to extend

Job Description:

Emerging Regulations team- manages regulations and works with cross functional 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 backgrounds not just in Regulatory Affairs but also from engineering, quality, and manufacturing, who are willing to look for a career in Regulatory Affairs.”

About Kyyba:                                                                                                    
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development. 
Disclaimer: 
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.
Rewards:
Medical, dental, vision
401k 
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client 
 
SELECT AWARDS

• An INC 5000 company for 10 years
• Corp! Michigan Economic Bright Spots 
• Crain’s Detroit Business Top Staffing Service Companies in Detroit
• TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
• Best of MichBusiness winner in HR Wizards & Partnerships
• Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
• 101 Best & Brightest Companies to Work for in Michigan