Essential Duties and Responsibilities (Other duties may be assigned):
- Ensure the Complaints Handling process runs smoothly, and complaints are handled in a timely manner
- Responsible for processing complaints to assure that complaints are documented, reviewed, evaluated, investigated, and formally closed in a timely manner.
- Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility.
- Prepare incident reports – FDA (Medical Device Reporting – MDR) and EU (Vigilance Reports) Reports, as needed.
- Interfaces directly with internal and external customers and indirectly with regulatory agencies, as required.
- Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities.
- Partner with cross-functional departments such as Engineering, Clinical, and Field Specialists on investigating product complaints and ensuring the timely completion and closure of complaint activities.
- Review Returned Materials Authorizations (RMA) against Customer complaints including related Service Reports and process accordingly. Maintain and file records in a timely manner.
- Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint.
- Assist in Quality System audits with various government agencies, private companies, and consultants.
- Identify, generate and publish metrics and reports related to the Quality issues such as complaints, field failures, and nonconforming materials.
- Analyze and trend post-market surveillance data.
- Supports the conduct, documentation, and closure of field correction and removal (recall) activities when needed.
- Manage documentation on all recalls, product safety issues, field actions and failures to health authorities as required.
- Execute validation testing of new or update to existing products (Device and Software).
- Responsible for maintaining state of the art in applicable external standards per the requirements of MDR and managing the gap assessment of new or revised standards.
- Perform manufacturing audits – when needed
- Responsible, along with the Supplier Chain Manager, for maintaining supplier relationships and providing supplier qualifications and audits. Interface with Suppliers for new processes, quality issues and process improvements for assigned projects
- Performs other duties as required
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Education and/or Experience:
- Bachelor of Science degree or related area of study or equivalent experience
- 3-5 years of related work experience with complaint handling, MDR/Vigilance reporting for a medical device company
- Excellent written and oral communication skills along with good presentation and technical writing
- Works independently in a team environment.
- Takes initiative and proactively seeks quality solutions through continuous improvement
- Effective priority setting
- Must have good analytical and problem-solving skills
- Strong working knowledge of Microsoft Office applications
Communication Skills:
This position requires excellent written and verbal communication. Ability to effectively present information in one-on-one and small group situations to suppliers and other employees at all levels of the organization.
- Must have excellent verbal and interpersonal skills.
- Ability to work successfully with a variety of internal and external sources
Reasoning and Technical Ability:
- Ability to manage multiple priorities in a high pressure environment.
- Requires high degree of technical comprehension of appropriate ISO and FDA medical device regulations, safety standards of FDA’s GMP regulations (QSR 820), 21 CFR 803 (Medical Device Reporting) and IS013485
- Ability to write clear logical investigation and technical reports Excellent verbal and written communication skills Strong organizational skills along with strong attention to detail
- Ability to contribute and collaborate in a creative, fast-paced and team oriented environment.
- Excellent problem-solving skills.
- Ability to create and execute effective plans to address issues/goals.
- Working knowledge of current revisions:
- EN ISO 13485 Medical Devices – Quality Management System
- MDD 93/42/EEC: Medical Devices Directive
- MDR EU 2017/745
- EN ISO 14971 Medical Devices – Application of Risk Management to Medical Devices
- 21 CFR Part 820: FDA Quality System Regulation
- 21 CFR Part 803, Medical Device Reporting.
- IEC 62304, Medical Device Software – Software Life Cycle Processes
- AAMI TIR 32, Software Risk
- Knowledge of Vigilance (MDD) and TGA Reporting Requirements
- FDA Guidance, General Principles of Software Validation
- FDA Guidance, Off-the-shelf Software use in Medical Devices
Computer Skills:
- Word processing, Spreadsheets, Internet software, E-mail, database software
Supervisory Responsibilities:
Work Environment:
- Minimum travel may be necessary
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
The noise level in the environment is moderate.
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.
While performing the duties of this job the employee is frequently required to stand; sit and use hands to finger, handle, or feel. The employee is occasionally required to lift up to 50 pounds. The vision requirements include: ability to adjust focus, depth perception, distance vision and close vision.
Accommodations:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Source: Indeed.com
Click Here To Apply
