Supplier Quality Engineer-Medical Device

Our client in South San Francisco, CA is looking for hardworking, motivated Supplier Quality Engineer to join their team. You will be an expert in Medical Device products. Don't wait... apply today!

• Title: Medical Device Supplier Quality Engineer (contract)
• Pay range $75 - $85/hr
• Location:South San Francisco, CA
• Onsite
• NO C2C, USC or GC only, W2 only

What You Will Achieve
The following summary is a partial list of the responsibilities associated with your job and is intended to illustrate initial job function. Due to the dynamic nature of the job, your duties and responsibilities may change over time.

As the Supplier Quality Engineer you will be responsible for providing Quality Engineering support and leadership for day-to-day operations of Supplier Management and activities relating to supplier selection, evaluation, and performance.functional teams to resolve quality issues and transfer NPI.

• Ownership and reporting of quality issues associated to suppliers
• Manage supplier performance to achieve organizational quality objectives
• Report on supplier performance and participate in review of supplier performance
• Participate in supplier monitoring processes which include: supplier audits, technical assessments and investigations, process validations, Material Review Board (MRB), and supplier corrective action requests (SCARS
• Expert in qualification and process validation of equipment and facilities for medical devices.
• Provide validation and qualification guidance to customers for equipment and computerized systems related to medical device, laboratory instrumentation and related utilities (e.g., water, nitrogen, etc.).
• Provide guidance, lead, or co-lead projects, manage own time to meet objectives.
• Plan and coordinate the validation/qualification work assigned i.e., QA review and approval of validation system life cycle documents including Validation Plans, IQ/OQ/PQ, vendor assessments, design documents, reports, procedures, and periodic reviews.
• Review and approve change controls including assessment for validation impact and identification of appropriate testing to ensure maintenance of the validated state.
• Work with Contract Manufacturing Operations, Quality, Technical groups, and other site/network groups as required assisting with establishing business and compliance requirements of instrumentation and processes.
• Ensure the validated state of equipment, instruments, and systems supporting manufacturing is compliant with corporate policies and regulatory requirements.
• Participate and/or lead quality investigations including root cause analysis, Human Performance assessments, and approval of investigation reports.
• Trend, investigate, and follow-up on supplier non-conformances
• Initiate and follow-up on SCARs to ensure effective problem resolution at supplier sites
• Maintain Approved Supplier List (ASL) through review and approval of new supplier requests, change requests, and supplier selection plans
• Support site during external audits (ie BSI, FDA, AATB)

BASIC QUALIFICATIONS

• Bachelor's Degree or minimum 9 years' industry experience in multiple disciplines
• Minimum 3 years of experience in medical device/IVD/Combination products
• Broad technical knowledge related to the design/operation of medical device or drug combination product platforms, design controls, risk management, 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR
• Familiar with regulatory requirements and guidance

Why should you choose Experis?

• Medical, Dental, Vision, 401k
• Weekly pay with direct deposit
• Consultant Care support
• Free Training to upgrade your skills
• Dedicated Career Partner to help you achieve your career goals

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.