Our client seeks a highly talented and experienced Quality Engineer who will be responsible for combining design control expertise, creative problem-solving approaches, and who will have strong analytical skills to support new product development and product maintenance using Quality Engineering.
In addition, this position will play an active role in the processes to ensure products meet quality standards consistent with both corporate and unit policies, while meeting all design control and other regulatory requirements for electro-mechanical devices.
Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products
Consistent application of technical principles, theories, concepts, and quality sciences / tools
Review and have Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
Ensure quality conduct of projects, including design, data summary and interpretation and report generation for self and developers
May provide guidance and work direction to other team members
Design and perform development working independently within defined parameters with minimal supervision required
Interested applicants should have:
Bachelor’s degree in engineering, science or a related field, and at least 10 years' Quality Engineering experience in the medical device industry.
Thorough understanding of industry regulations: QSR/cGMP, ISO QM standards including ISO13485, ISO149741, IEC60601, IEC62304 and EU MDD/MDR, and will have experience with electromechanical device and device software standards and requirements.
Be a dynamic problem solver, able to anticipate potential problems and create solutions.
This is a superb, all-round R&D engineering career development role with a world leader in medical devices.