Sr. Quality Engineer
Description
· Develop, modify, apply, and maintain quality
standards.
· Collaborate with engineering and manufacturing
functions to ensure quality standards are in place.
· Develop and implement methods and procedures for
inspecting, testing, and evaluating products and production equipment.
· Perform statistical analysis of product/process
performance.
· Ensure documentation is compliant with
regulatory requirements.
· May specialize in design, production control,
product evaluation, and/or reliability as they apply to product or process
quality.
· Perform and/or review process validation and
equipment documentation, including URS, FAT, IQ, OQ, PQ, and TMV (excluding
cleaning and laboratory processes).
· Support investigations of manufacturing
operations events and assess manufacturing defects/rejects trends.
· Support design requirements validation and
manufacturing controls for projects (not Operational Excellence initiatives).
Requirements
- 3–5 years of experience in a regulated industry (Medical Devices, Pharma, or Biotech).
- Experience with Risk Management documentation (pFMEA).
- Basic knowledge of statistics (preferably using Minitab).
- Knowledge of validation strategy design (requirements flow-down from design to manufacturing).
- Bachelor in Engineering completed
- Experience in CAPA, investigations, and technical writing.
- Knowledge of Medical Device regulations.
Nice to Have
Change Control of Medical Devices.
Equipment Commissioning / Qualification.
Process Validation.
Computer System Validation (CSV).
Experience with Manufacturing, Packaging, and Laboratory Equipment.
Technical troubleshooting experience.
Background in Quality, Process Control, or Assurance within Medical Devices.
Investigation and root cause analysis skills.
Strong technical writing, organization, and communication skills.
Experience developing/updating pFMEA, Control Plans, and Process Flows.
Computer software programming knowledge.
Advanced knowledge in Process Validation and CSV.