SUMMARY:

The Vigilance Specialist is responsible for

Assessing for Adverse Events (AEs) and completing complaint records in a timely manner.
Reporting of AEs to relevant regulatory authorities within the required timelines
Reporting and co-ordination of FCAs both internal and external within the required timelines

ESSENTIAL DUTIES AND RESPONSIBILITIES

Evaluate incoming complaints through various paths.
Ensure all complaint information/data is accurately captured.
Maintain the complaint record in the PLM.
Performs follow up activities to obtain additional information.
Liaise with Engineering to provide investigation report.
Document investigation results based on technical analysis provided.
Ensure record documentation is maintained in a state of audit readiness.
Interact with Technical Service, Manufacturing, R&D;, and Quality Assurance, as needed, during the course of complaint processing.
Identify and document appropriate complaint categories to enable trend accuracy.
Review and interpret risk management files and assign appropriate hazards.
Perform appropriate evaluation steps to ensure all available information is present so to determine.
complaint reportability
Coordinate Adverse Event Reporting and Field Corrective Action processes.

Assist with the Product Correction and Removal process.
Coordinate group meetings to ensure that all tasks have been assigned and completed.

Collect and report metrics to support Management Review and process improvement activities.
Maintain training for Quality System procedures related to the role which can affect the quality of products or services provided to our customers.
Effective team member, fully motivated to achieve and demonstrate best practices in line with the goals of the quality department.
Support/Drive Quality System related project activity as required.
Supports the activities associated with preparing the QMS to maintain certification to MDSAP (FDA, MDR, ANVISA and other regulations) as well as ISO13485:2016 and MDR requirements.




Provide Quality System support for Regulatory Audits.
Provide periodic training for company personnel on the company’s Quality Systems processes and procedures.

Other duties may be assigned.

SUPERVISORY RESPONSIBILITIES:
N/A

QUALIFICATION REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND/OR EXPERIENCE:

A third level qualification in an engineering or scientific discipline (Electronics, Mechanical or Chemistry

Sciences, Physics, Natural Sciences or related).

Minimum of 2 years’ experience in a similar role within Medical Device industry; a combination of education and experience in Quality Assurance
Internal auditor certification/experience advantageous but not necessary.
Knowledge of:

21CFR, Section 820, Quality System Regulation
21CFR Section 803, Medical Device Reporting
ISO 13485, Quality Systems, Quality Management Systems

Complaint handling experience or customer service/technical support experience (0-2 years)
Strong analytical skills (problem solving, critical thinking)
Excellent organizational; problem solving; decision-making; communication (oral and written);

and influencing skills.

Excellent communication skills (oral and written), with strong organizational and analytical skills.
Ability to work independently or in a team setting.
Good technical capabilities, communication skills,



teamwork abilities and initiative
Proven ability to work well both as part of a team but also able to work on own with minimum supervision.
Microsoft Office proficiency required.
Proven ability to review and analyze quality critical technical documents.
Knowledge of statistical packages, (e.g. Minitab) preferred but not required.

LANGUAGE SKILLS:

Ability to read, analyse and interpret general business periodicals, skilled standards, and technical procedures.
Ability to write reports, business correspondence and procedures.
Ability to effectively present information and respond to questions from peers and management.

MATHEMATICAL SKILLS:

Ability to calculate figures and amounts such as discounts, interest, commissions, percentages, area, circumference, and volume.
Ability to apply concepts of basic algebra and geometry.

REASONING ABILITY:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear.
The employee is regularly required to work at a keyboard and computer.
The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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