BD is looking to ensure quality by design in their laboratory services, specifically focusing on method development and execution compliance with quality standards, cGMP requirements, and continuous improvement of their Quality Management System (QMS).
Requirements
- Strong knowledge of design control, risk management (ISO 14971), and verification/validation principles.
- Experience with mechanical and analytical testing of drug-device combination products.
- Familiarity with 21 CFR Part 820, 21 CFR Part 4, and ISO 13485.
- Proficiency in statistical analysis tools and quality engineering methodologies (e.g., Gage R&R, DOE, FMEA).
- Technical writing knowledge and skill. Ability to author Quality System documentation, reports including review of data and data analysis.
- Experience with Laboratory Information Management Systems (LIMS) a plus.
- Experience managing or participating in audits a plus.
Responsibilities
- Lead and execute design verification testing activities for combination products in accordance with FDA 21 CFR part 210,211, 820, ISO/IEC 17025 and ISO 13485
- Develop and review test protocols, methods, and reports to ensure compliance with design control and risk management requirements.
- Ensure laboratory compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Support root cause investigations, CAPA, OOS/OOT and non-conformance resolution related to design verification testing.
- Maintain and improve quality systems, including CAPA, Nonconformances, calibration and maintenance and equipment qualification.
- Conduct timely reviews of project documentation including but not limited to protocol, laboratory data, audit trails, and reports prior to release to the client
- Review Test Method Validation and provide quality expertise in the development of test methods and protocols
Other
- Collaborate with cross-functional teams including technology development, operations and business development to support flawless project execution and delivery management.
- Provide technical guidance and mentorship to junior engineers and laboratory staff.
- Participate in internal and external audits, including regulatory inspections.
- Stay current with evolving regulatory expectations for combination products and contribute to continuous improvement initiatives.
- Excellent analytical, organizational, and communication skills.
