Job Description Summary:
We are seeking a Quality Engineer II to support the coordination and management of Post Market Surveillance reports.
Key Responsibilities:
* Collect, analyze, review, trend, and report on product safety data to identify potential adverse safety risks or performance trends.
* Collaborate with cross-functional team members to ensure compliance with applicable regulations, standards, and company policies/procedures.
* Work closely with different functions onsite and between other BD sites in Europe and the US.
* Identify development and training opportunities for the PMS team.
* Participate in projects to align with BD Quality, MDD/MDR strategies, and regulatory submissions.
* Extract and generate PMS and operational performance data necessary for generating applicable reports.
Requirements:
* Bachelor's degree in Engineering or a technical field.
* Experience in technical writing and project management.
* Proficient in Excel, Windows OS, and Microsoft Office Suite.
* Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971, and EU MDR.