Job Summary
A results-driven Quality Engineer with expertise in risk management, process validation (IQ, OQ, PQ), test method development, and quality system improvements. Skilled in conducting root cause investigations, supplier qualifications, and regulatory compliance to ensure seamless operations.
Adept at collaborating with cross-functional teams, supporting audits, and driving continuous improvement through data-driven decision-making. Committed to maintaining the highest industry standards and enhancing quality processes for operational excellence.
About BD
We are the makers of possible. At BD, we help our customers make a difference in healthcare by advancing the world of health through medical research, diagnostics and patient care solutions. Our vision for Peripheral Intervention at BD is to offer a comprehensive range of medical products, devices and services for the treatment of peripheral arterial and venous disease, cancer detection, and end-stage renal disease and maintenance.
The Role
The Quality Engineer will work ensuring compliance, driving process improvements, and maintaining the highest industry standards collaborating with cross-functional teams to represent quality interests and facilitate seamless project and process transfers into production. Proficient in drafting, reviewing, and updating risk management documentation (p FMEA), test method validation protocols, and process validation reports (IQ, OQ, PQ) to uphold product integrity and regulatory compliance.
Experienced in developing inspection procedures, test methods, and statistically valid sampling plans to optimize quality control. Will conduct root cause investigations, data verification, and gap analysis, identifying opportunities for continuous improvement, and implementing quality system enhancements through change management.
This role requires expertise in supplier qualification, internal and external audits, and regulatory compliance alignment to maintain seamless operations. A proactive problem-solver with a meticulous approach to monitoring and managing quality metrics, supporting internal, corporate, customer, and notified body audits, and ensuring adherence to global and corporate quality management standards, policies, and regulations and committed to excellence in quality assurance, risk mitigation, and operational efficiency would be the perfect candidate.
Main Responsibilities
Represent quality interests and concerns in conjunction with a cross functional team. Provide support for project/process transfer to production. Lead Quality Engineering activities as part of a cross functional team. Drafting, reviewing and updating risk management documentation, as required e.g. p FMEA. Drafting and execution of Test Method Validation Protocols and Reports.
Develop or assist in the development of inspection procedures and test methods for Receiving Inspection, In Process inspections or Final Release Testing. Determination of appropriate sampling plans based upon valid statistical rationales and historical data. Review of Process Validation Documentation (e.g. IQ, OQ, PQ). Completion of Data Verification activities.
Support qualification activities for new suppliers and new component qualification, as required. Identification of quality system improvement opportunities and execution through the change management system. Completion of root cause investigations for nonconformances, as required. Completion of Gap Analysis activities.
Responsible for compilation and communication of data for Management Review, as required. Provide support for audits including internal, corporate, customer and notified body audits. Participate in internal audit or supplier audit programs, as required. Ensure alignment of the quality system with changes in global and corporate quality management standards, polices or regulations.
Management and monitoring of Quality Metrics, as required.
About You
Third level Engineering/Technical/Science Qualification. Min 3 years' experience in the medical device or pharmaceutical industry. Preferred Knowledge and Skills: Working knowledge of ISO 13485 and its applicability to the manufacturing environment. Experience with risk management, particularly p FMEA and familiarity with ISO 14971.
Experienced in use of statistical software packages e.g. Mini Tab. Experience in the execution of all stages of Gage R&R / Test Method Validation. Experience in auditing (internal and / or supplier), Lead Auditor Qualification is advantageous. Working knowledge of change control processes, non-conformance & CAPA. Working knowledge of c GMP and cleanroom requirements.