Quality Engineer

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embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X.

A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.

Quality Engineer

Reporting to the Quality Operations Manager, this role supports product and process development, non-conformance investigations, lot disposition, and the application of SPC to production. Responsibilities include coordinating with QA/QC labs, approving validation studies, managing complaint investigations, supporting change controls, and leading or contributing to process improvements. The role also involves preparing, reviewing, and approving technical documentation. This role would suit an experienced Quality Engineer that has worked in a high volume production environment.

Responsibilities:

• Managing the activities of the Quality Inspectors to ensure optimal efficiency and compliance with all regulatory requirements;
• Drive root cause analysis of non-conformances with relevant personnel and ensure corrections are implemented before starting back to production after a quality issue;
• Drive and maintain cGMP practices across all operational departments under your quality responsibility (Incoming, assembly, packaging, warehouse) and attend departmental and other meetings as appropriate;
• Release batches in SAP from packaging to sterilization and final release & Complete DHR reviews and batch releases;
• Liaise with relevant personnel regarding flow of product through QC department and other issues that arise;
• Review, analyze and report on relevant customer complaints and institute corrective actions.

Education & Experience

• A degree in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering).
• Previous work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry and experience in a production environment.
• Experience of preparing technical documentation and a good knowledge of Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
• Experience in CAPA system management and a working knowledge of FDA requirements and managing FDA audits. Good knowledge of SAP and Track wise
• Previous experience of working in process validation and a clean room environment .
• The ability to work within a cross functional team
• Excellent interpersonal and communication skills coupled with a high level of computer literacy.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesMedical Device

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