Description : The Quality Specialist will perform complaint investigation activities for product complaints and Adverse Events with cross functional team members and provide complaint investigation reports in compliance with Solta procedures, Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System requirements, and other regulatory guidelines.
Reports To: Materiovigilance Manager
Principle Responsibilities and Duties:
Note: The following are meant to be representative but not necessary all-inclusive of the duties and responsibilities for this position title.
- Works independently to investigate root cause of product related complaints and adverse events in compliance with company procedures.
- Identifies applicable corrective and preventative actions to facilitate complaint closure.
- Manages timelines for complaint investigation to ensure that investigations are performed in a timely manner.
- Develops or contributes to development of quality processes for complaint handling.
- Provides technical input for adverse event investigations.
- Perform periodic trend analysis as a Post Market Surveillance early warning system on complaint data.
- Perform Post Market Surveillance trend analyses. Generate or apply statistical methods with appropriate risk-based justification.
- Lead or support Post Market Surveillance related projects to improve source data required for Post Market Surveillance activities.
- Other duties as assigned.
Experience, Education, Training, Traits:
- 4 years bachelor level degree in Science, engineering or other similar discipline.
- Minimum of 1-3 years of experience within Medical Device Industry is preferred.
- Technical writing in English required
- Working knowledge of FDA QSR, ISO 13485:2003 and applicable global regulatory requirements for complaint handling.
- Working knowledge in risk management for medical devices is required
- Excellent skills at tracking, trending, analyzing and reporting key quality metrics for complaint history using electronic database systems.
- Knowledge and experience working with software systems used for complaint handling and/or other relational database experience is preferred.
- Demonstrated analytical capabilities with the ability to summarize data into graphs, charts and statistics using any software (Excel, Minitab, SQL, PowerBI, etc.) is required.
- Basic understanding of programming languages (Python, SQL, Java, etc.) is preferred.
Language and Verbal Skills
Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Analytical and Reading Skills
Ability to read, analyze, interpret and assist in the creation and refinement of company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. Ability to calculate figures and apply mathematical concepts like statistics.
Must be comfortable working in a company environment with rapidly evolving needs, responsibilities and expectations.
Solta Medical is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.
Web Reference : AJF/358527983-202
Posted Date : Thu, 30 Jun 2022
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