Senior Quality Engineer
Posted on Jan 31, 2019 by Anonymous
The primary responsibility is in providing Quality Engineering support to NPI (New Product Introduction), Operations, Engineering and Quality Management functions.
Furthermore, you will lead the development of validations and change management initiatives in compliance with Medical Device Manufacturing Regulations and customer requirements. You will be required to interact with multiple Customer and company functional teams to achieve organizational objectives. You will have responsibility for supporting the product design and manufacturing through the application of Quality engineering skills also for multiple quality related projects and tasks, from product inception through product launch and process support.
* Assist with development of quality and operating systems to assure alignment with current GMP/QSR, and ISO requirements.
* Manage Associate Quality Engineers and Quality Engineers as required.
* Lead Audit backroom operations for external audits.
* As assigned, participate in new product transfers and be responsible for the development of quality plans, verification of engineering tests and measurement practices for new and existing products using QA Tools.
* Active participation in the review of engineering specifications to assure that quality assurance requirements are met and designs are successfully transferred into manufacturing.
* Development of process controls using valid statistical techniques inclusive of SPC systems, sampling plans, correlation analysis etc.
* Takes a leadership role in assuring all activities in the area of equipment and process validations meet FDA and EU regulatory requirements.
* Development of IQ/OQ, Process Validation test protocols and reports to support product development and manufacturing process changes in compliance with customer's control procedures.
Skills, Abilities and Education
* A bachelor's degree in engineering or a related field and/or a combination of practical and educational experience in the medical device industry is required.
* Preferred experience: minimum of three (3) years' experience in medical device quality assurance with a background of working in a regulated manufacturing environment.
* Experienced in Process Validation to Medical Device Regulatory requirements.
* Ability to develop and write protocols, validation reports, engineering reports, etc.
* Experience in Project Management.
* Working Knowledge in Analytical, Statistical techniques including SPC and inspection and test methodologies
* Demonstrated knowledge in FDA and ISO requirements including recent QSR experience. Participation in FDA & other Regulatory bodies audits is desirable.
If you feel you have the relevant skills and experience, please apply with a copy of your cv