Employer
Meet Recruitment
Posted
Monday, June 30, 2014
Closes
Friday, July 25, 2014
Ref
JKQEIRE
Location
Ireland
Job Role
Contract Type
Hours
Salary
above market average
Further information
Overview:
Quality engineer/consultant opportunity, Ireland. Contract role at a global medical device company which is looking for support on a huge project win. The successful Quality Engineer will have 3+ years experience preferably as a contract/consultant in the medical device industry. Great opportunity, possibility of extension or turn to permanent.
Roles and Responsibilities:
· Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies
· Drive and implement plant wide quality system improvements.
· Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
· CAPA Management, support Engineering and Manufacturing teams and lead CAPA investigations as required
· Collate and trend quality data relating to product robustness, conduct analysis and recommend necessary technical solutions to drive effective corrective action.
· Conduct detailed root cause analysis on design related non conformances, developing effective preventive measures to prevent recurrence.
· Key member of New Product Introduction teams, transfer and implement product and processes from development or from another manufacturing facility.
· Reviews risk hazard analysis and D-FMEA updates on new product or product changes, mitigating risk and controlling compliance to Risk Management and cGMP requirements.
· Support P-FMEA activities with QA and or Process Engineering group.
· Provide technical support for new product transfers from other facilities, writing Quality Plans, and monitoring status of executables to ensure smooth transition into established QMS.
· Conduct Internal Audits against schedule as part of Audit Team.
· Participates in external regulatory audits in areas of their responsibility
Essential Experience:
- Engineer/Science qualification (Minimum BSc or BEng) with minimum of 3-5 years working within QA/RA in a multi-national medical devices manufacturing environment
- Excellent working knowledge of ISO 13485 and 21CFR820, along with exposure to other regulations. Working familiarity with IEC 60601 a distinct advantage
- Experience with leading and participating in several projects concurrently.
- Ability to accurately scope projects and consider the full impact of decisions and actions taken.
Location: Ireland
Rate: above market average
Contract: 8 months
Full job description and company details are available upon application, apply below. This position is being dealt with by Jake Kitchen at Meet, contact on - +447794527518 or email directly at Jake@peoplewithchemistry.com to discuss further. Apply now
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