Quality Assurance Specialist

4 weeks ago

Mounds View, United States Integrated Resources, Inc ( IRI ) Full time

Must Have:

• 0-3 years of medical / clinical experience or exposure


Nice to Have:

10. Computer literacy in MS Word, Excel, PowerPoint

Complaint Handling


JOB DESCRIPTION

Top 3 things the manager is looking for in a candidates experience:

Complaint handling &/or medical device experience would be a plus.

Strong analytical skills.

Strong communication skills

Top 3 Tasks or Responsibilities in Product for this role:

Application of end-to-end complaint handling process with focus on product analysis and investigation summaries.

Writing & reviewing investigation summaries that meet compliance requirements.

Collaborating with key stakeholders involved in product analysis and investigation summaries.

Education Required: Bachelors degree

Years’ Experience Required: > 1 year is preferable

Location: Can be Lafayette or Mounds View (Minneapolis)

Role is hybrid – 2-3 days in the office. Hours are generally 8-5.


Description:

Associate MDR/Vigilance Specialists are responsible for the intake, documentation, Medical Device Reporting, and investigation of complaints for Endoscopy products in accordance with applicable internal procedures (work instructions) and external requirements (regulations or guidance from all regulatory bodies).

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

Receive and assess product comments to determine need for complaint handling record.

Document required information in Global Complaint Handling (GCH).

Assess complaint file for missing required information. If information is missing, initiate attempts to gather information. Steps may include contacting:

*** Field Personnel

Health Care Providers

Patients or other initial reporters

Communicate with outside parties in a professional and customer-focused manner that is in following with our Mission and enhances the *** brand.

Evaluate incoming product events to determine MDR and Vigilance reporting eligibility.

Initiate, complete regulatory reports for timely submission to FDA and other regulatory bodies.

Determine if investigation is necessary. If investigation is necessary, determine:

Potential cause and contributing factors to the alleged event.

Device relationship.

If formal device investigation is necessary.

Summarize the results of any investigation.

Escalate complex issues to management.

Execute other projects as assigned.

Qualifications

Must Have: Minimum Requirements

Bachelors degree with 0 years’ experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation


Nice to Have

High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc.)

0-2 years’ experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation

Degree in Health Care, Sciences, or Bio-Medical Engineering

Strong attention to detail

Knowledge of basic anatomy, physiology, and medical terminology

Knowledge of:

21CFR, Section 820, Quality System Regulation

21CFR Section 803, Medical Device Reporting

ISO 13485, Quality Systems, Quality Management Systems

45CFR, Parts 160 and 164, Patient Privacy Rule- HIPPA Regulations

AIMD Directive: 90/385/EEC

IVD Directive: 98/97/EC

MDD Directive (Council Directive 93/42/EEC for Medical Devices)

PC 1998-783 - Canadian Medical Device Regulation (CMDR)

Complaint handling experience or customer service/technical support experience (0-2 years)

Strong analytical skills (problem solving, critical thinking)

Excellent communication skills (oral and written), with strong organizational and analytical skills

Ability to work independently or in a team setting

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Template Job Description: Responsibilities may include the following and other duties may be assigned. Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations. Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies. Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries. Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

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