Senior Quality Engineer - 24 month contract - Medtronic Mervue
Job description
Medtronic
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
Our Purpose
At our Quality Engineering in Medtronic, plc, we focus on providing Quality support to the manufacturing and operation processes for Medtronic Mervue Galway. Quality Engineers are directly involved in ensuring compliance to Quality System requirements on our Ventilator and Patient Monitoring production processes.
Come for a job, stay for a career!
A Day in The Life Of:
- Define, implement, and maintain and improve Quality System requirements in the form of Quality Assurance.
- Supervise personnel within an area of the Quality Department. Take the lead in this area.
- Develop and modify Procedures and other related procedures
- Participate/support the Management Review Process.
- Provide reports/information to management on quality related issues and define and implement solutions to quality related issues.
- Participate in and lead cross-functional teams as directed by the Quality Manager.
- Participate in and lead internal/external audits as required.
- Ensure that product conforms to specification and control further processing, delivery on installation or non-conforming product until the deficiency or unsatisfactory condition has been corrected.
- Ensure that preventive and corrective actions are taken in relation to product and Quality system deficiencies and initiate, recommend or provide solutions to product and Quality system related problems.
- Interface with other departments to ensure that Quality system requirements are adhered to.
- Participate in and initiate job-related training courses.
- Follow all environmental, health & safety rules and procedures and participate in safety and environmental activities to improve the workplace for all employees.
- Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science)
- 5-8 years’ experience in a medical devices or related environment with direct experience in a QA environment (GMP regulated).
- Excellent working knowledge of Quality System Requirements within the Medical Device/Healthcare industry
- Knowledge of FDA and ISO compliance
- Must be capable of carrying out documentation related responsibilities as well as technical responsibilities
- Ability to work well as part of team and also to lead a team
- High level of interpersonal communication and organizational skills, along with the ability to positively influence project teams.
- Ability to take initiative, to organize and prioritize own work and proactively contribute to project level strategies and planning.
- Effective time management skills.
- Ability to write engineering documents, test protocols, FMEAs
- Good working knowledge of statistical data analysis and quality improvement tools and techniques preferable.
- Able to analyze and chart data using MS Excel or Minitab
- Previous Quality Auditor experience is desirable, or certification is an advantage
- Experience in Design Quality is desirable
Medtronic offer a competitive salary and flexible Benefits Package
This position is an exciting and new opportunity to work with Medtronic’s Patient Monitoring, Respiratory Interventions and /or Medical Care Management Systems businesses. Currently a part of Medtronic, these business es are being transitioned either into a new stand-alone company (currently referred to as NewCo) or will be merged into the business of another company. While you will start your employment with Medtronic, upon establishment of NewCo or upon the transition of the business unit to another company, in approximately 12-15 months (if we can designate timing; this was in the public announcement) your employment will transfer to one of these entities and you will no longer be employed by Medtronic .
The business will have the same singular focus, financial commitment, deep domain expertise, and global footprint needed to accelerate the development and commercialization of affordable and scalable health care technologies.
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