Description
Quality Engineer - Limerick, Ireland
Provides leadership and support to Water Room and Formulations process, and ensures good Quality Engineering practices are in use. Drives continuous improvement through data driven approaches and monitoring of quality systems.
Job Responsibilities
Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes
Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO). Addresses and corrects product and process complaints.
Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management
Responsible for supporting the activities of Operations/Engineering/information management in building quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness
Leads and executes upgrades to Quality System Support QA programs in assuring compliance to the pertinent regulation Identify and lead cost and technical improvements under the departments' continuous improvement program. Provide key inputs and leadership into transformational process developments.
Lead or actively participate in cross-functional teams to ensure New Product Introduction/Research and Development projects are completed in a timely and efficient manner.
Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements.
Demonstrate strong leadership and a clear identifiable work ethos within the team.
Ensure effective closure on Quality System documents (Audit Actions, NCR's, CAPA's, Maps, etc).
Ensure all process developments, NPI etc are managed in accordance with the Quality management system.
Implementation of safety/environmental requirements on purchase of all new equipment. Work with team leader to develop and implement strategic engineering
Non Technical Skills and Additional Details
Experience in a regulated environment.
SIX SIGMA - Certification
Experience in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA)
Experience of the design and qualification documentation standards to current FDA expectations
Knowledge of statistical packages and Microsoft Office systems required.
Proven ability to review and critique Quality Critical technical documents.
A good understanding and working knowledge of FDA and ISO regulations.
Knowledge of lean manufacturing
Experience as Quality Engineer working in a cGMP environment preferably in medical device.
Positive attitude
Continuous Improvement orientation
Accepting of change
Flexible - Calmly reacts to the unexpected .
Additional information about the process
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services