Quality Engineer II, Risk Management
6101 Stoneridge Drive Pleasanton, CA 94588 US
Leading an active lifestyle is important to the many people we serve. Client is advancing the treatment of heart and vascular disease through breakthrough medical technologies in heart failure, allowing people to restore their health and get on with their lives.
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
• 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) product.
• 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 timely manner.
• Skill with Microsoft office- Word/Excel/Powerpoint
• IBM Rational Doors skill desirable
target pay: 50-52/hr
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.