Job Overview:
Responsible to execute risk management processes, procedures and documentation required to support quality risk management program for surgical procedures and new combination product development.

Summary of Responsibilities:
- Work with the team to execute risk management processes, procedures and documentation required to support quality risk management program. _Focus will be on combination products that could be used in surgical procedures so an understanding of surgical procedures will be helpful _
- Providing quality oversight to current combination product development as well as lifecycle management.
- Deliver technical reports fully in compliance with cGMP's
- Collaborate and build trusting relationships with all stakeholders and business partners in identifying opportunities for improvement and meeting goals and objectives ( _This will need calls/meeting in US time _)
- Collaborate on data driven risk assessments (risk identification, analysis and evaluation) and formulate risk mitigation plans as well as support Corrective and Preventive Action (CAPA)



plan initiatives.
- Executing the functions as called out in Standard Operating Procedures.
- Coordination of documents in the document management system.
- Be accountable to assure quality & compliance with procedures and customer requirements.
- Identify potential issues, perform trouble shooting, resolve conflicts and provide solutions for technical documentation related activities, coordinate the issues in a timely manner.
- Working with company leadership to define project objectives, processes, policies, procedures and rules.
- Well versed with product knowledge.
- Participate in cross-functional meetings as needed.
- Responsible for cascading relevant information from internal and external meetings to appropriate colleagues.
- Assist with the generation, review and implementation of SOPs, Work Instructions, etc.

Qualifications (Minimum Required):
- Bachelor’s in pharmacy or related science d

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