What are the responsibilities and job description for the Regulatory Affairs Manager position at Advanced Bifurcation Systems Inc.?
Responsibilities
The Senior Quality Engineer will collaborate with cross-functional teams to develop and implement controls and drive improvements. They will ensure that workflows, processes, and products comply with safety regulations, investigate and troubleshoot product or production issues, develop corrective actions, solutions, and improvements, and review specifications and processes.
Key Responsibilities:
- Develop and maintain quality systems and documentation in compliance with FDA, ISO, and EUMDR requirements.
- Lead and/or support on-time completion of design control deliverables for both new product introductions and design change projects.
- Support design verification/validation planning and execution, including any cross-functional investigation and resolution activities.
- Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.
- Lead risk management activities from product concept through commercialization.
- Support Product development activities and design transfer into manufacturing.
- Support Manufacturing Engineering in the creation, release and maintenance of DHR/LHR, bills of material, and specifications for manufacturing.
- Assist in the selection, qualification, and assessment of new suppliers based on established procedures.
- Conduct supplier audits to evaluate their capabilities, processes, and quality management systems.
- Develop establish and maintain periodic reviews with suppliers on their performance(scorecards), and improvement or corrective action plan(s).
- Support nonconforming material investigation and disposition activity, participate in weekly MRB meetings, follow-up on supplier issues.
- Assist with maintenance of calibration system.
- Perform incoming inspection review and disposition of product components and subsystems.
- Assist in investigations of quality issues arising from product complaints, CAPAs, and non-conforming reports.
- Utilize problem solving tools to analyze and identify root causes and implement corrective actions.
- Actively participate in the Doc-Control process.
- Support the Environmental monitoring process.
- Initiate /approve validation protocols and reports (IQ, OQ, PQ).
- Initiate /approve process validation protocols and reports.
- Other duties and responsibilities as mutually agreed.
