This is Rohith from Intellectt INC; we've got an important role Process Engineer WYNNEWOOD, OK with one of our prestigious clients. Interested candidates can please send your updated resume at

Role: Quality Engineer II

Location: Pleasanton, CA - 94588
Duration: 12 Months on W2
Shift Timings: 8 AM to 5 PM

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 the 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