What are the responsibilities and job description for the Contract Position - Business Process Specialist (3 months) position at REVA Medical, LLC?
As directed, Business Process Specialist is accountable for the successful implementation of nonconformance processes, Corrective and Preventive Actions (CAPA), and electronic batch records (EBR) within the medical device manufacturing process. This position is responsible for deploying these systems in an electronic Quality Management System (eQMS) and providing comprehensive training to ensure effective adoption and compliance. The successful candidate will collaborate with cross-functional teams to oversee the transition of the quality system processes from a paper-based system to an electronic system.
Duties:
- Develops and implements Nonconformance, CAPA, and Electronic Batch Record processes using the Dot Compliance eQMS, a Salesforce based system
- Write, edit, and submit for review Standard Operating Procedures, Work Instructions, and process guides for processes within scope
- Develop and provide training workshops and materials for cross-functional teams
- Collaborate with internal and vendor teams to develop and implement custom software functionality as necessary
- Provide routine updates to management regarding adherence to project plan, accomplishments, roadblocks, and risks.
- Perform system testing as required and compliant to company policies and procedures
- Suggest process improvements based on industry experience and domain knowledge
- Other duties as assigned
Skills/Qualifications:
- Bachelor's degree and a minimum of 1 year industry experience. Candidates with relevant experience from internships and co-ops are encouraged to apply
- Experience implementing eQMS systems and/or Salesforce based systems is required
- Experience in regulated industries is preferred. Knowledge of ISO 13485 and 21 CFR 820 is strongly desired
- Exceptional communication (verbal and written) and interpersonal skills are required. This role requires administering business process training to all levels of the organization.
- Must be detail-oriented with excellent analytical and problem-solving skills.
- Proficiency with MS Word, PowerPoint, and Excel is required
- Positive attitude, honesty and a team player mentality.
Willingness and ability to take on additional tasks and projects as assigned.
