Senior Quality Engineer

Location: Galway city, Galway, Ireland
Date Posted: 01-23-2018
Job Title: Senior Quality Engineer
Division: Quality
Reports To: Quality Manager
Location: GALWAY
Industry: Medical devices
Our client is a global medical devices manufacturer.  The company has an excellent reputation as an employer locally in Galway, with a good work-life balance and excellent staff retention rates.
Position Summary
The Senior Quality Engineer provides a support role to the Quality Manager in the routine maintenance of the Quality Management Systems and in Quality related projects.    The Senior Quality Engineer reports to the QA & RA Manager.
Duties and Responsibilities
•             Possesses and applies comprehensive knowledge of Quality, and its application within the company, to the completion of complex assignments.
•             Advanced knowledge of the organization’s operations and practices to enable informed decisions, and providing direction to Quality team and other functional areas.
•             Responsibility for delivery of projects originated in QA or participate within Core Team for Quality deliverables of business wide projects.  
•             Identifies key barriers/core problems and applies problem-solving skills in order to deal creatively with complex situations. Troubleshoots and resolves complex problems with effective solutions.
•             Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results.  Applies risk assessment techniques in such circumstances. 
•             Independently performs assignments with instruction limited to results expected.  Determines and develops approach to solutions.
•             Drives business improvements through mentoring and support for the continuous improvement initiatives.
•             Escalation point for quality related non-conformances and CAPAs.
•             Drives compliance cross functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification. 
Minimum Qualifications & Skills
•             Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits.
•             Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
•             Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
Education & Experience
•             Third level qualification.
•             Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions, including;
•             competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
•             awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
•             Broad knowledge of engineering and technical applications applied in development of medical devices useful.
Job Characteristic Profile
•             Understands the business strategic direction and is able to pro-actively conceive and develop a training plan which is aligned.
•             Pro-actively identifies potential future skill gaps and plans accordingly.
Manages Complexity
•             Is familiar with broad suite products.
•             Understands the different dynamics with each team and adopts his/her approach accordingly.
•             Partners where necessary with peer groups within and outside the company.
•             Is comfortable and confident in interfacing with senior management.
•             Can positively influence employees at all levels on the need for continuous skill enhancement.
•             Can interface professionally with external auditors.
•             Can develop plans and policies to meet continually changing business needs.
•             Identifies best practice training organisations and implements learning in Alere.
•             Continually seeks to improve the effectiveness of training across the business.
Results Driven
•             Implements his/her plan with 100% attention to detail and success.
•             Associates directly with all customer related metrics across the site and builds connectivity of training plans in support of same.

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