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