JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life.
Today our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve.
Description
The globalDesign Assuranceteam for IDEM, the Infectious Diseases Emerging Market Business Unit, supportsR&D, Marketing, Clinical Operations, RA, QA and manufacturing functions based in Europe, Asia and US. The team is responsible forDesign Controlthroughout the lifecycle of NPI projects, fromideationthrough toproduct launchincluding sustainment, for realization of our Lateral Flow Diagnostic Devices. The team supports a rapidly expanding business unit within Abbott.
To ensure we can rapidly expand ourDesign Assurancecapability, we are recruiting aDesign AssuranceEngineer that will strengthen the team through implementation of best practicedesign controlswithin our projects.
TheDesign AssuranceEngineer role will be instrumental inshapingthe NPI Project deliverables to support our IDEM newproduct developmentpipeline. They will provide direction to and ensure compliance across all our Core Teams and Extended Teams –R&D, Marketing, QA, RA, Clinical Operations and Manufacturing.
The specific role initially will be focused on a number of exciting newproduct developmentopportunities and participate on cross-site or cross Business Unit Core Teams to ensure standardisation of project deliverables in compliance with best-in-classdesign controls. Please note this position is a 12 month FTC
Responsibilities and Duties
- Promotes the awareness of regulatory and customer requirements throughout the organization.
- Remediation of currentDesign Controlprocedures and practices across sites to standardise to “best in class”design controls. Liaise withqualitysystems and regulatory affairs personnel within the Business Unit to ensure team’s compliance and to drive alignment and harmonization.
- Deploymentof effective training collateral to ensure compliance todesign controlpolicies with the Core Teams, Extended teams and relevant functions within the Business Unit.
- EmbedDesign Assurancein all stages of the design concept and feasibility to supportR&Dthrough specification setting, test development and provision ofstatistical samplingto ensure robust prototypes and design at design freeze.
- Support new test development and appropriate test method validation.
- Provision of on-going risk management,design control,qualitysystems and overalldesign assuranceexpertise and leadership to the Project Core and Extended teams.
- Perform technical reviews ofdesign documentationand labelling, attend atdesign reviews,coordinateand facilitate completion and update of design risk management documentation and acts as independent reviewer for all design activities including design changes.
- Escalate where appropriatedesign controlconcerns/ issues in a timely manner to ensure project schedule maintenance.
- Design ControlSupport for audits including Abbott Corporate Audits and external Regulatory/ Governing Body audits (e.g. FDA/ WHO).
- Ability to work is a matrix organisation where project deliverables are accountable to the Program/ Workstream Leader.
Requirements
- Primary Degree level qualification in Science, Engineering or Technology, plus 2-3 years ofQuality Engineering/Design Assurancework experience within a regulated environment (ISO13485/ FDA).
- Formal training in Medical Device Risk Management,Process Validation,Software Validationand problem Solving would be beneficial.
- Excellent data analysis skills.
- Proven ability to work well as part of a team and on own.
- Excellent communication skills to support virtual project requirements.
- Clear demonstrated experience in working in a diverse cultural environment.
- Excellent presentation skills to facilitate communication throughout the organisation. In addition, excellent use of virtual communication technology is required for effective workshop leadership and change management.
- Travel pending company policy, global and country regulations to Asia and Europe.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ID Infectious Disease
LOCATION:
Ireland > Galway : Parkmore East Business Park
ADDITIONAL LOCATIONS:
WORK SHIFT:
Ie - 37.5Hst0 (Ireland)
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable