Global, Supplier Quality Engineer III
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POST DATE 5/18/2017
END DATE 8/16/2017
San Diego, CA
JOB DESCRIPTIONA FANTASTIC OPPORTUNITY FOR A TENURED QUALITY SUPPLIER ASSURANCE ENGINEER IN OUR BEAUTIFUL SAN DIEGO OFFICE IN MIRA MESA.
This role provides technical and quality support for supplier selection, qualification, and approval. There will be responsibility for ensuring that the supplier audit program is implemented in compliance with existing procedure requirements including audit schedule and execution, supplier auditor qualifications, adequacy of audit reports, and on time closure of audit non-conformance's.
TASKS AND RESPONSIBILITIES:
Apply QSR 21 CFR Part 820 (Medical Devices) to everyday application of Supplier Quality Management activities.
Support the qualification of new suppliers/services provides according to company policy.
Execute duties per the Supplier Quality Audit program.
Execute and support activities to ensure effective monitoring of supply chain performance including supplier corrective actions (SCAR) reporting
Support the creation and management of quality agreements with vendor.
Manage supplier change control and work with the Operation/Quality engineering group to evaluate the change impact to product performance.
Lead and drive proactive supplier quality tools (e.g. scorecards, supplier risk management) and participate in supplier business reviews.
Leading and/or supporting supplier related Non-conformance and CAPA.
Carries out duties in compliance with established business policies.
Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
Perform other duties & projects as assigned.
PREFERRED EDUCATIONAL BACKGROUND:
Bachelors Degree in a biological science or engineering discipline.
PREFERRED EXPERIENTIAL BACKGROUND:
* 2-5 years of relevant medical device experience
* Working knowledge of the technical principles related to in-vitro diagnostic device function
* Lateral flow device experience is plus.
* Ability to read, interpret and understand technical and non-technical documents including product drawings, specifications, contracts and purchase orders
* Experienced in root cause analysis and corrective action processes.
* Working understanding of regulations relating to in-vitro diagnostic medical device products (e.g. 21CFR Part 820, EN ISO 13485, EN ISO 14971:2012, CMDR).
* Must be able to work independently
* Experience with 21 CFR 820.50.
* Excellent analytical skills.
* Excellent written and verbal communication skills
* Must be organized and detail oriented
* Must be able to work independently
* Attention to detail, including thorough documentation of activities in a fast pace environment.
* Working knowledge of process validation and design control.
* Proficiency with Microsoft Office, Word, Visio and Excel.
* ASQ Certified Quality Engineer or equivalent experience desired
* Ability to travel approximately 10% to 15% domestic and international.
* Must be able to demonstrate the ability to be a part of a team (e.g. Procurement, Manufacturing, R&D, Quality and Working with site leadership team).
* Must be able to step out of their comfort zone to help other members of the team at a moments notice.
All listed tasks and responsibilities are deemed as essential functions to this position, however, reasonable accommodations will be made if at all possible under business conditions