Senior Quality Engineer

　　Our client in South San Francisco, CA is looking for hardworking, motivated talent to join their team. Don’t wait… apply today!

　　What's in it for you?

　　Payrate or Pay range $75 - $85/hr

　　Location:South San Francisco, CA

　　Onsite

　　Supplier Quality Engineer (Contract)

　　Why Patients Need You

　　Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.

　　This is a position that will either be onsite in Emeryville or San Jose, CA or remote.

　　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. The SQE will also be involved in continuous improvement programs and other projects as required. This position requires frequent travel to conduct supplier audits. Other duties are maintaining the ASL, evaluating new supplier requests, facilitating supplier corrective actions, and working with cross-functional teams to resolve quality issues and transfer NPI.

　　How You Will Achieve It

　　• 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

　　• Act as a liaison between suppliers and NPI and Sustaining cross-functional team to evaluate and address quality requirements and/or issues

　　• Manage cost reduction and continuous improvement initiatives with suppliers as required. Ensure the efficient and timely transfer of process knowledge from supplier to project personnel and internal quality and manufacturing engineers as necessary

　　• Escalate potential supplier and compliance issues, providing key input into decision making

　　• Support site during external audits (ie BSI, FDA, AATB)

　　• Perform other duties as assigned

　　BASIC QUALIFICATIONS

　　Bachelor’s Degree or minimum 9 years’ industry experience in multiple disciplines

　　Minimum 3 years of experience in pharmaceutical industry

　　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

　　Excellent communication skills and attention to detail

　　Effective communications skills required, both written and verbal.

　　Requires strong interpersonal skills and the ability to handle multiple projects.

　　Fluent in English both speaking & writing

　　Good knowledge of MS Office

　　Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. 

　　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

　　Are you Interested?

　　Share this job with friends and family and earn dollars with every successful hire.

　　ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.