Job Title – Risk Management Project Manager II
Our client in Pleasanton, CA 94588 is looking for hardworking, motivated talent to join their team for a global medical device and healthcare company that seeks to bring life-changing health technologies to people who need them all over the world.
Don’t wait… apply today!
What's in it for you?

• Payrate or Pay range: $50-$55/Hr.
• Onsite
• Contract
• Full time

Position: Risk Management Project Manager II
Location: Pleasanton, CA 94588
Duration: 12 Month (Possible Extension)
Description:
Quality Engineer II, Risk Management - Heart Failure
We are seeking a highly motivated Quality Engineer to support our Risk Management team. You will work closely with development/manufacturing/quality engineering to establish and ensure compliance and quality for product related risk management documentation. Ensure risk management assessments and evaluations for products conform to established standards and agency regulations.
What You’ll Do

• Perform risk evaluations associated with complaints, manufacturing non-conformances and new product design activities.
• Works cross functionally with Engineering, Marketing, Manufacturing, Clinical and Regulatory to establish product risk documentation.
• Work collaboratively with operations engineering, complaint handling team, product development and design assurance.
• Understands how to comply with ISO 14971, U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments as related to risk management and product quality.
• Understands Risk/Hazard analysis, Risk Management Reports, Benefit Risk Analysis, Risk Management Planning, FMEA techniques.
• Understand Hazards, Hazardous Situations, Harms, Risk Analysis/Acceptability, Risk Controls, Implementation/Verification of Risk Control
• Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
• Maintains risk documentation and establishes procedures that affect department.
• Ability to perform gap analysis between standards/procedures and in use documentation.

Education And Experience, You’ll Bring
Required

• A bachelor’s degree in an applicable engineering discipline or life science with minimum 2 plus years of progressively more responsible work experience in quality assurance and design related to medical devices, preferably in electro-mechanical and implantable medical devices (class III and IV).
• Experience preferably in an Implantable Medical device, regulatory environment, or pharmaceutical manufacturing. Preferred understanding of complaint management and Health Hazard Assessments for on-market (distributed) products.
• Excellent verbal and written communicator; clear and concise in communications with internal and external partners.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work effectively within a team in a fast-paced changing environment.
• Multi-tasks, prioritizes and meets deadlines in a timely manner.
• Skill with Microsoft office- Word/Excel/PowerPoint
• IBM Rational Doors skill desirable

If you’re interested in the role, drop your resume.
Please let me know if you have any questions — and I’m also happy to refresh your memory on the details of the project and the role I played if you want me to send anything over.
The application takes about 2-3 minutes, and I will keep a sharp eye out and get an interview scheduled ASAP.
Thanks so much for your time, and I look forward to a more formal intro!
Are you Interested?
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