Abbott Rapid Diagnostics (formerly Alere) is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
As we embark on this exciting journey, the Abbott Rapid Diagnostic Division (ARDx) is searching for a Supplier Quality Assurance Specialist 2 to join our team. This is a great opportunity to leverage your strong technical expertise while growing your career with a premier industry leader. If you seek a dynamic role where your contributions will pave the way in developing exciting new products, then come and work with us!
This position will work at the San Diego site, located in the beautiful Sorrento Valley, where we manufacture critical protein and small molecule components for multiple Abbott Rapid Diagnostics products, with a focus on cardio metabolic diseases, infectious diseases and toxicology.
This role provides technical and quality support for ensuring the Supplier Quality system is being managed effectively as part of the Supplier Quality Administration group. There will be responsibility for ensuring that the Supplier Quality System process is compliant to internal and external requirements
TASKS AND RESPONSIBILITIES
* Apply QSR 21CFR Part 820 (Medical Devices) to everyday application of Supplier Quality Management activities.
* Supports the supplier corrective action process, including issuing nonconformance reports (e.g. Minor Audit Findings (Quality Incidents), Supplier Corrective Action Requests (SCAR)) where applicable.
* Tasks include bounding/containment of nonconformance's, tracking corrective action completion, evaluating effectiveness of the supplier's planned solution and implemented solutions.
* Execute and support activities to ensure effective monitoring of supply chain performance including supplier corrective actions (SCAR)
* Follows up with suppliers on audit findings and drives suppliers for continuous improvement.
* Support the qualification of new material/service suppliers according to company policy.
* Prepares and presents accurate reports to management related to supplier performance. Enlists SQA management assistance with supplier roadblocks and lack of responsiveness.
* Support proactive supplier quality tools and participate in supplier business reviews.
* Leading and/or supporting supplier related Non-conformance.
* Supports Supplier Quality Assurance team by cross training in all department functions.
* Manage Non-Conformance Report Forms and ensures completeness of the non-conformance file.
* Assign, review and conduct investigations regarding non-conformance trends.
* Assists internal customers with preparation of non-conformance forms.
* Conducts internal audits to verify compliance of the site Quality Management System to applicable internal procedural requirements and external standards and regulatory agency requirements.
* Identifies internal nonconformance's to procedural and regulatory requirements.
* Excellent critical analytical skills - ability to find root cause of why an issue occurred. Ability to review action plans and determine if the actions taken effectively address the issue
* 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 company's policies and practices.
* Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
* Carries out duties in compliance with established business policies.
* Perform other duties & projects as assigned.
Bachelor's Degree preferred.
* Must have at least 2 to 4 years' experience working in a professional environment where compliance was of vital importance. Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic. Experienced in root cause analysis and corrective action processes.
* Working understanding of regulations relating to in-vitro diagnostic medical device products (e.g. 21CFR Part820, EN ISO 13485).
* 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.
* Proficiency with Microsoft Office, Word and Excel.
* 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 moment's notice.
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to ...@alere.com.