Sr. Supplier Quality Specialist

Glaukos•Burlington, MA

About The Position

As a critical member of the Global Quality organization, the Sr. Supplier Quality Specialist I will support the oversight of suppliers/vendors utilized by Glaukos in the development, manufacturing, and/or distribution of medical devices and pharmaceutical products. This person has primary responsibility for performing supplier/vendor assessments, on-site inspections, and monitoring performance of vendors/suppliers in accordance with the Supplier Quality Management program. This person will lead and drive assurance of Supplier Quality performance to ensure that suppliers meet all identified regulatory and Glaukos specific requirements impacting component and/or product quality. Initiate, support, and lead, as applicable, the supplier quality related initiatives with suppliers to improve product quality and on-time delivery of contracted goods/services. The individual will work closely with internal cross-functional impacted areas, such as Supply Chain Operations, logistics, research development, internal R&D quality and CMCs as well as all the external vendors. Under the guidance of the Senior Director of Quality Assurance this individual will be the point person from the supplier quality for supporting all the activities associated with supplier quality.

Requirements

Bachelor's degree preferred.
5-8 years relevant work experience in a medical device manufacturing work environment in a quality discipline.
Working understanding 21CFR 210, 211, Annex 1, 21 CFR Part 820, ISO 13845 and ISO 14971 requirements
Strong knowledge of regulations applicable to pharmaceutical and medical device manufacturing. Experience in performing Quality System and supplier audits is highly desirable.
Strong documentation skills, attention to detail and accuracy
Strong written/oral communication skills
Ability to work cooperatively and effectively in a team environment.
Experience in Suppler Management with manufactured products.
Experience with Quality Management Systems (QMS), Root Cause and Corrective Action.
Demonstrated ability to work in a team environment.

Nice To Haves

ASQ certifications preferred. CQA, CBA, CQE, CSSBB

Responsibilities

Work with cross functional department to review and approve requests for new suppliers to determine the supplier risk level and supplier qualification requirements.
Determine classification risk level and qualification requirements for new suppliers.
Work with suppliers and legal department to create new or redline quality agreements and maintain quality agreements to support all the supplier’s quality requirement.
Maintain “Approved Suppliers List” (ASL) information in Oracle regarding the part numbers and service types for suppliers.
Submit and review changes to supplier classification, supplier risk level and supplier status.
Take necessary actions, including issuing Supplier Corrective Action Requests) to improve supplier performance.
Support maintenance of the Supplier Quality Records
Supplier Assessment schedule development and execution, including leading on-site and or on-site supplier audits.
Update supplier profiles or documentation as needed related to supplier changes.
Lead supplier performance management by analyzing performing data, identifying opportunities for improvement, and driving action on suppliers.
Drive resolution of Supplier Corrective Action Requests (SCARs).
Track SCAR performance and verify the long term effectiveness of corrective actions.
Ensure continuous improvement and optimization of Supplier management procedures and processes.
Own the elimination of supplier product risk to improve reliability across the product lifecycle. Engage in Quality activities from concept through development and manufacturing to field use, with internal teams and suppliers.
Ensure the execution of product and process requirements with suppliers. Define and improve such requirements.
Manage the Supplier Change Notification process, ensuring timely internal evaluation, risk assessment, and implementation of controls.
Collaborate cross functionally to assess regulatory and operational impact of supplier initiated changes.
Work cross-functionally to ensure Glaukos quality standards are being met. Facilitate smooth communication between the product team and suppliers.
Participate in the evaluation and improvement of suppliers. Frequent local car and occasional domestic air travel to visit suppliers (up to 50%)
Support the continuous improvement of the Quality Management System. Define and improve required documentation and activities.
Support investigations, initiatives, and projects as needed, at the team or organization level.