About the Role
The Quality Engineer will ensure that complaints are properly investigated and documented, as well as verify that outgoing units comply with stated guidelines. In addition, the position supports the resolution of customer issues in order to determine the cause of the problem and to initiate the appropriate corrective action.
Key Activities
Ability to lead product quality investigations to a successful conclusion.
Perform pre-release final inspection on medical devices, flagging and trending any non-compliances.
Identify and help facilitate continuous improvement, corrective and preventive actions (CAPA).
Interface with other departments as necessary to assist in CAPA execution.
Collect, analyse, trend and communicate quality data throughout the organisation.
Conduct risk assessments, gather supporting information, and provide recommendations to management.
Ensure daily procedures and work instructions are in accordance with established internal procedures, ISO 13485, ISO 9001 and FDA GMP/QSR
Contribute to the maintenance of the ISO 13485:2016 quality system manual.
Plan and conduct internal and external process audits and facilitate ISO facility audits.
Provide support in product investigations.
Experience with validation (IQ, OQ, PQ).
Preferred Skills
Experience with statistical analysis preferred.
Basic ISO 13485:2016 audit and procedure writing knowledge.
Professional quality certification (i.e CQE, CQA, Lean Six Sigma) preferred.
Education and Experience
A four-year engineering degree is required or a similar technical discipline.
Minimum 5 years related experience in a regulated environment, preferably medical devices, but automotive, aerospace, or pharmaceuticals are considered.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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