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We are seeking a highly skilled Medical Device Design Controls Specialist to join our team. As a specialist, you will be responsible for leading the analysis, investigation, and documentation of trends at a product performance level for post-marketing surveillance data.
This role requires a strong background in medical device design controls, post-market, and risk management experience, with a minimum of 5-8 years of experience. You must also have a solid understanding of quality planning, quality system requirements, and standards gap assessment. The ideal candidate will possess excellent communication and presentation skills, with experience working with cross-functional teams.
You will lead project teams and franchises in the execution of quality deliverables, collaborate on clinical evaluation reports, and act as a lead team member in continuous improvement projects to ensure post-market surveillance reports are completed efficiently and compliantly. You will also investigate potential and/or identified trends or data issues with cross-functional teams across divisions.
The successful candidate will have a strong ability to analyze complex data, identify trends, and develop recommendations for improvement. They will also have experience working with regulatory agencies, such as the FDA, and be familiar with industry standards, including ISO 13485 and ISO 14971.
