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embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit  embecta.com  or follow our social channels on  LinkedIn ,  Facebook ,  Instagram  and  Twitter .

As a Supplier Quality Engineer, you'll lead the charge in quality for materials in insulin delivery devices and their suppliers. Your role will involve conducting supplier audits, inspections, and non-conformance investigations, as well as proactive monitoring and effective communication.

Responsibilities:

Supplier Quality:

• Manage all aspects of the Quality System with respect to Supplier quality, including procedures, risk assessments and ASL.

• Liaise with corporate supplier quality on projects, as required.

• Maintain the supplier audit schedule and execute supplier audits as required.

• Contribution to OCP Supplier Management process, as appropriate.

• Provide support for the ISO13485 and 21CFR Part 820 Quality Systems.

• Ensure adherence to all embecta and external regulatory requirements.

• Become an active member of the site internal audit team.

• Prepare and maintain supplier related documentation in compliance with the appropriate regulatory requirements.

• Support projects to identify and qualify new/ alternative suppliers

• Support production personnel in relevant continuous improvement activities (Six Sigma etc.).

• Act as customer liaison contact for key customers as appropriate.

• Review, analyse and report on relevant customer complaints.

Materials:

• Ensure line of sight from material specifications, supplier in-process and final release testing, embecta in-coming inspections, sample size and acceptance criteria, to ensure a dependable supply of suitable quality materials to support production.

• Review and approval of Quality related documents.

• Generate documentation appropriate to task (e.g. ECO’s, Material Specification etc.).

• Provide assistance to interested parties on materials issues as requested.

• Manage the development of new and improved materials.

• Represent Supplier Quality at daily production meetings

• Lead response to supplier related QNs in day to day production, driving supplier investigations, responses, etc

• Any other reasonable duties which may be required by management from time to time

Educational & Experience

• A primary degree in a Science/Engineering/Technical discipline.

• 4+ years work experience in an ISO 9001 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry is preferred. Other industry experience considered.

• Experience in the preparation of Technical Documentation.

• Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).

• Experience in CAPA system management.

• A working knowledge of FDA requirements and managing FDA audits.

• Proven ability of working in a cross-functional team environment.

• Excellent interpersonal and communication skills and high level of computer literacy.