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Quality Engineer IV

Santa Clara, CA 95054

Posted: 05/01/2024 Employment Type: Contract Job Category: Engineering Job Number: 606073 Is job remote?: No Country: United States

Job Description

Description / Summary:
This role will provide compliance support to the Regulatory Affairs organization by:

a. Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics.
b. Managing strategic program for RA audit preparedness including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks.
c. Supporting quality system integration for acquisitions and new product introductions.
d. Identifying and implementing system and/or systemic processes.
e. Supporting tracking and maintenance of regulatory post-approval commitments.
f. Driving quality system process improvement initiatives

Initiatives include but are not limited to:

1. Establishing audit support for integration products,
2. Improving and Maintaining the quality system procedures (e.g., change management)
3. Liaising with cross-functional partners and international affiliates to meet audit compliance needs and driving to implementation/resolution.
4. Participating in audit backrooms, and
5. Participating in RA projects.

Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus.

List of tasks:

• RA Change Requests Tracking and Closure
• Change management
• Develop and implement an “auditing plan” for critical RA tasks (e.g., mock audits for Technical Files/Technical Documentations, Impact Assessments, Archival) as part of audit risk mitigation activities.
• CAPAs/Auding Finding management.
• Post-Approval Commitments management
• Support QMS audits from an RA perspective
• Support QMS Integration tasks
• Management Review Metrics results

• Independent
• Troubleshooting
• Critical thinker
• Ability to drive a problem through resolution and implement mitigations.
• Ability to handle multiple streams simultaneously.

Consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations and Product Performance Analysis teams to ensure compliance to LifeScan software development procedures and industry regulations. Review and approve deliverables of the software development lifecycle. Lead teams in performing Hazard Analysis. Occasionally assist teams in developing Standard Operating Procedures and Work Instructions for software development activities that meet their specific needs. Occasionally provide training for select software development activities for LifeScan. Occasionally write and execute test protocols and reports. 7+ years

Pay ranges betwwen $45-50/hr based on expereince 
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About Santa Clara, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area around Santa Clara, California. Located in the heart of Silicon Valley, this region offers unparalleled growth opportunities in tech, innovation, and beyond. With attractions like Levi's Stadium, the Santa Clara Convention Center, and the nearby California's Great America theme park, there's always something exciting to do. Indulge in the diverse culinary scene, catch a show at the Triton Museum of Art or the historic Santa Clara Theatre, or cheer for the San Francisco 49ers at Levi's Stadium. Discover why Santa Clara is the perfect place to elevate your career and enjoy a rich blend of culture and charm!

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