Global Biotech company seeks motivated Quality Engineer to join their growing team. This individual, in conjunction with the R&D team, will develop, revise and maintain quality standards for product and equipment, methods and procedures for inspecting, testing to ensure the precision and accuracy of products and/or production equipment.
Key activities include, but are not limited to the following:
- As a partner with manufacturing, create and/or modify methods and procedures to ensure that appropriate tests are conducted and that products, materials, and manufacturing equipment meet required standards
- As part of the Quality team, ensure the overall compliance of product, process and quality assurance activities for the development and commercial support of various Applied Biosystems’/Life Technologies products.
- As a core team member on new product development teams, provide quality engineering services to assigned projects ensuring that defendable engineering and scientific analyses are employed and that design history files comply with established requirements.
- risk management
- analytical method validation
- process/product verification and validation
- labeling, packaging, and stability activities
- quality and regulatory plans
- Reviews specifications to evaluate quality requirements including: proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods
- Recommends revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer
- Reviews and approves engineering change requests
- Applies together with other team members advanced techniques to ensure that quality is designed into products and processes, including Design/Process FMEA, DOE, Statistical Tolerance Analysis, Six Sigma, Quality control, etc.
- Works closely with Development and Manufacturing Engineering to resolve potential quality related issues during and after new product launches.
- Responsible for the investigation, and resolution of related quality issues
- Review and resolve Material Review Board (PRB) issues through coordination of efforts across operations and at incoming.
- Support product continuation by assuring the quality of the components used in the manufacturing floor, working supplier/component quality related issues to resolution, and participating in supplier audits.
- A candidate for this position shall have a BS degree or advanced degree in Bioengineering, Biochemistry, Chemistry, Molecular Biology and a minimum of three years experience in instrument development for the biomedical or biotechnology industry.
- 17 months ago - save job