A Senior Project Quality Engineer is required by CareerWise Recruitment for our Galway based client. The Senior Project Quality Engineer requires significant project management experience as well as being very experienced in new product introductions. Please contact Tom Devaney for more information.
Role of this position
- Demonstrates commitment to the Quality Policy (product safety and quality) through the daily execution of sound quality practices.
- Leads quality related projects within the Device Manufacturing Value Stream e.g. where significant process changes are required that originates from a CAPA or a customer complaint.
- Leads cost improvement projects and NRE activities within the value stream from a quality perspective.
- Leads quality support for the transfer of new product into device manufacturing.
- Provides additional support to the operations team when a new product is introduced to the value stream where required until the product has reached steady state.
- Completion of TAP analysis for new products introduced to the value stream.
- Leads validation activities within the value stream in conjunction with the validation group including MVP's, MVR's, TMV's, OQ/PQ, PPQ and revalidation assessments.
- Manages the approval of supplier change notifications.
- Supports audits for the value stream from external regulatory agencies and customers and leads preparation activities in advance of such audits.
- Updates quality procedures, specs as required through the change plan process.
- Provides root cause analysis & problem-solving guidance and mentoring.
- Level 8 degree in Science, Engineering or related subject.
- 5-7 years' relevant supplier quality / quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry.
- Significant project management experience.
- Very experienced in new product introductions.
- Excellent knowledge of equipment qualifications, test method validation and process validation.
- Ability to work as a team member and to provide mentorship to other team members.
- Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role.
- Good organization and investigation skills are required.
- A Black Belt qualification would be an advantage.
- Excellent "hands-on" technical skills.
- Excellent communication skills.
Please call Tom Devaney today for further information on 091-758771 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)