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n this role, the R&D student will supervise an R&D production line, support operational R&D activities such as testing coordinating, tooling calibration.

In addition will be responsible to perform various testing throughout product development phases, from initial concept tests to feasibility and engineering tests.

The individual will bring excellent analytical, technical, and organizational skills to the execution of development projects.



Essential Duties and Responsibilities:

Manage and maintain the engineering assembly pilot line for SmartDose 10ml sample builds.
Performs, coordinates and documents feasibility, engineering, and failure investigation related testing activities.
Perform tests using laboratory equipment, such as tensile/compression/torque testing machines (Testometric, Instron), Magnifying Glass, Analytical Balance, Data Logger, Environmental Chamber, etc.
Performs per need general maintenance activities on R&D tools, equipment, and machinery.
Support validation of products
Support industrialization and manufacturing activities
Support procurement per need
Support commercial Production Line engineering

In this role, you will be supporting Engineering and R&D departments as well as being involved in QA activities.

The QA engineer position is temporary for 2 years (project support).

Essential Duties and Responsibilities:



QA focal point for engineering projects in design and development processes.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations, and standards.
Responsible for final approval of engineering documentation- reviewing and approving technical, mold and process validation documentation (IQ, OQ, PQ).
Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
QA representative in equipment and process validation reviews
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects.
Attend program meetings as required as part of extended program teams.
Provide support, when necessary, with review and approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, OOSs, protocols, reports, product design transfer)
Support other QA dept activities- second approval of batch release/graphics, routine sterility validation maintenance activities (dose audit and bioburden), calibration etc.
Responsible for final approval of engineering documentation- reviewing and approving test method validation
Competencies/Authorities

Approve equipment qualification documents (URS, pFMEA risk documents, IQ, OQ, PQ)
Approve validation protocols and reports.
Support all engineering activities.

The Quality Engineering & Manufacturing Manager will support continuance improvement of product, process and QMS and provide guidance and support to all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards and its subcontractors. The Quality Engineering & Manufacturing Manager will also lead a team executing the QMS related transactions in relevant GMP systems (MasterControl, SAP, Share Point) and other relevant quality functions as applicable including external and internal audit support.

Essential Duties and Responsibilities:



Exhibit a strong quality first mentality and ensure that product, process and QMS are held to the highest standard.
Provide guidance on Ops, technical and engineering processes/documentation to ensure compliance to procedures, relevant regulations and standards.
Lead Sr. Quality Eng., team leaders, Quality Engineers and Quality personnel in the day-to-day activities- supervise performance and tasks handling, set priorities, training, and objectives according to the organizational goals.
Lead Sr. Quality Engineers and QEs who review and approve technical/ Engineering documentation (DMR, IQ, OQ, PQ, product specifications, process validation and qualification activities, FMEA risk documents, test methods, protocols, reports, OOSs, design transfer, etc.) in relation to medical devices.
Lead the Quality involvement in design and maintenance of product and production process and hazard analysis in accordance with policies and procedures.
Provide Quality oversight and guidance to design transfer and process qualification and validation activities to other Sr. QEs.
Provide quality oversight, approval and guidance for qualification documentation and reports
Provide direction and guidance with problem solving techniques for technical and process reviews in cases of escalations.
Lead the sites device sterilization methods establishment, validation, maintenance and routine controls as the site sterilization SME by verifying that the sterilization methods validation is done according to the applicable standards and regulations. Verify the sterilization methods and risk-based approach are routinely maintained. Address sterilization issues and provide solutions to sterilization challenges. Be a part of the Global Sterilization Council and provide support to other CM and Medical device sites with Ster