Overview
Skills
Job Details
DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
Visit us at to learn more and view our open positions.
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Hema Malini at
Prawin at
Description
- This section focuses on the main purpose of the job in one to four sentences.
- This position is responsible for complaint handling, will triage incoming complaints for the assigned team, and will process all levels of complaints without supervision.
- Will need strong writing
- This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.
- The incumbent will perform other duties assigned.
- Triage incoming complaints from internal or external customers to determine next steps in the process based on level of risk.
- Collect necessary complaint information for investigations.
- Determine the reportability of a complaint. Respond to customer complaints (written or verbal) and write technical investigation response letters.
- Participate in continuous improvement activities and projects (ie: CAPA, Product Improvement Teams). May lead projects as assigned by management.
- May have technical approver responsibilities.
- Manage workflow; identify and escalate issues.
- Participate in mentoring and training of the Product Surveillance team.
- Ability to perform all duties required of previous levels.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- Strong knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 806, 820, and 211).
- Understanding of the products' intended use and the manufacturing process of assigned products.
- Strong technical writing skills, able to review complaint investigations and write customer response letters.
- Readily accepting of assignments to new/ different products.
- Ability to prioritize multiple risk projects to ensure compliance with regulations and standard operating procedures.
- Excellent written/verbal communication and organizational skills.
- Ability to make independent decisions with minimal oversight.
- Strong problem-solving and analytical skills.
- Knowledge and application of computer systems for word processing, reporting, data analysis and complaint management.
- The primary goal of writing the letters/Documents
- Manage customer complaints
- Adobe, Microsoft Office, familiar with AI tools
- Experience with QMS platforms, complaint handling system
- Familiarity with Good Documentation Practices (GDP) and regulatory standards.
- Include the education and experience that is necessary to perform the job satisfactorily.
- Bachelors degree required. 2-5 years relevant work experience in cGMP related industry or in a clinical setting.
- Interview: 2 Rounds
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.