Quality Engineer - JBL Resources

Our Client, the pioneer of and global technology leader in robotic-assisted surgery has an opening for a Quality Engineer in Sunnyvale, CA. With a commitment to improving healthcare, our Client stands at the forefront, building leading-edge, integrated systems and software to provide education and support that aims to keep hospitals and their staff at the forefront of minimally invasive care. Working at this company will provide you with a strong support system and the opportunity to make impact and grow your career. Want to work for an innovative company that brings about transformative changes in the healthcare system world-wide? This could be the opportunity for you!
Day-to-Day Duties May Include:

• Ensuring that quality systems, products, and manufacturing processes comply with quality standards by supporting robust root cause analyses, CAPA independent reviews, and remediation activities in accordance with international industry practices and regulations (e.g., ISO 13485, 21CFR820).
• Meeting objectives, providing support and expertise in corrective and preventive action (CAPA) process and system.
• Partnering with CAPA team and subject matter experts on various CAPA activities.
• Ensuring robust investigation of product quality and compliance issues within a closed-loop quality management system.
• Supporting and complying with company and site’s health, safety, and environmental programs and requirements.
• Complying with health regulatory and international standard (ISO13485) requirements, company and site policies, operating procedures, processes, and task assignments.
• Participating in review and completion of CAPA projects, assuring compliance, quality, and timeliness of records.
• Collaborating with cross-functional teams using various methodologies (e.g., Six Sigma root cause analysis/problem-solving skills).
• Providing CAPA subject matter expertise to independently review investigations and other quality events as applicable.
• Processing requests, ensuring subject matter experts and action item owners are assigned and provide timely responses in alignment with quality goals.

• Executing and providing on-time completion of quality engineering or quality plan deliverables.

Qualifications:

• Bachelor’s Degree in Engineering, preferably in Science or Healthcare fields.
• Minimum of 10 years’ experience as a Quality Engineer in Systems, Assurance, or Quality Control.
• Minimum of 10 years’ experience working in a regulated manufacturing industry such as Medical Device, Pharmaceutical, Biotechnology, etc.
• Minimum of 10 years’ CAPA and/or engineering experience and demonstrated use of quality tools and methodologies.
• Minimum of 8 years’ experience demonstrating knowledge of Quality System Regulations (21CFR820) and ISO 13485.
• Expertise in cGMP and CAPA documentation.
• ASQ certification: CQE, CQA
• Knowledge of process improvement tools and methodologies (Lean, Six Sigma) preferred. Green or Black Belt Certification in Lean or Six Sigma is a plus.
• CAPA Review and Approval experience preferred.
• Remediation experience preferred.
• NO C2C CANDIDATES

Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company