My client is Waterford based Medical Device company with exceptions growth opportunity within the organization! Because of such an increase demand, we’re recruiting for an experience Medical Device Quality Engineer. As the Quality Engineer, you will ensure that manufactured products meet both company and customer quality specifications. In your role as the Quality Engineer, you are also responsible for designing inspection sheets and assigning inspection levels and frequencies, troubleshooting Quality issues and assisting Engineering, Production and other Departments in maintaining the Quality Systems on site in compliance with ISO13485 and AS9100 requirements.
Duties of the role:
- Support NPI team in the execution of Performance Qualification for clean room processes as per the project schedule.
- Support deviation investigations throughout the facility.
- Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up related CAPA’s as required.
- Create concise and accurate on-time technical reports. Clearly communicate results internally and to customer through the use of quality tools and statistical techniques.
- SME for appropriate statistical techniques to monitor process performance such as SPC, Cp, Cpk,
- R&R analysis, sampling techniques and other statistical techniques.
- Work with the customer as a liaison for all quality related issues; Capable of articulating complex technical solutions to customers in a manner that’s easily understood.
- Creates and evaluates metrics to drive tangible quality improvement through the team.
- Evaluate materials, gather and analyse data and determine root cause of problems using relevant corrective action systems (e.g. CAPA / 8D / A3 Problem Solving).
- Manage several projects simultaneously and coordinate multiple, changing deadlines
- Proven solutions provider that can work in a fast pace environment across multiple projects with a customer focussed approach.
- Process driven thinker with a proven track record for delivering value add to the bottom line through CI initiatives.
- Exceptional technical report writing skills required with a logical flow to his / her approach
- Ability to lead environmental monitoring programs for cleanroom activities.
- Desire work effectively with minimal guidance and take ownership of your role.
Requirements of the successful candidate:
- Degree in Engineering; Mechanical/Manufacturing/Process or similar
- 5+ years’ experience in quality department in a manufacturing environment.
- 2+ years of experience in Customer Complaints Management
- Strong working knowledge of Reg requirements ISO 9001-13485 CFR 820 is essential
- Knowledge of cleanroom environmental monitoring
Able to independently work with quality tools and knowing when to implement them across teams, RC, Brainstorming, 5Why, Fishbone, CAPA, NC, NCMR, 8D, A3, SIPOC, Process Maps and Heat Maps.
Clean Room assembly experience
- Experience using 6 sigma
- Lead auditor qualification
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