Senior Quality Engineer/Quality Manager
- € 65000 - 75000 Per year
- Full time
- Job level
- Qualified (non-manager)
- 8 May 2019
- 5 Jun 2019
The primary responsibility is in providing Quality Engineering support to NPI (New Product Introduction), Operations, Engineering and Quality Management functions.
* 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.
* Performs special projects and other related duties as assigned.
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.
* Excellent written and verbal communication skills.
* Excellent interpersonal and organizational skills working with the domestic and global organisation sites and our customers.
* Ability to work in a high-intensity, fast-paced environment.
* Creative thinking and ability/desire to think "outside of the box".
* Team player