We have a job opportunity for you as a Quality Engineer IV. If you are interested in this role, then please send me an updated copy of your resume.

Job Details

Job title: Quality Engineer IV
Location: 3200 Lakeside Drive, Santa Clara, CA, USA, 95054
Pay range : $45- $50/hr on W2

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 implementation and resolution.
4. Participating in audit backrooms and
5. Participating in RA projects.

The role has the potential to investigate nonconformances (CAPAs) and implement 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 and technical documentation, Impact Assessments, and archives) 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

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

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of:Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands - Manpower, Experis, Talent Solutions, and Jefferson Wells - creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.