Associate Specialist, Quality Compliance

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision‑making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

How you will make an Impact:

Fulfill applicable medical device regulations in the region, ISO
13485 and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.

Investigate complaints with the support of higher level team member or manager

Evaluate event to determine if it qualifies as a complaint

Manage customer relationship and expectations during course of complaint investigation and resolution process

Assess complaint information provided and conduct additional investigation as needed and escalated as appropriate

Evaluate complaints for Medical Device Reporting to competent authorities

Prepare and submit reports to Competent Authorities, after review by more senior team member

Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions

Prepare and submit final customer correspondence, after review by more senior team member

Other incidental duties;
May identify problems with processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encountered

What you will need (Required):

Bachelor's Degree in related field, 1 years experience with complaint handling experience

Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment

What else we look for (Preferred):

Good computer skills in MS Office Suite and ability to operate general office machinery

Good written and verbal communication skills and interpersonal relationship skills

Good problem-solving and critical thinking skills

Basic knowledge of medical terms and human anatomy

Full knowledge of Medical Device Vigilance regulations, and regulatory reporting regulations

Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing

Ability to manage confidential information with discretion

Attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment with guidance

Must be able to work in a team environment, including immediate supervisor and other team members in the section or group

Ability to build stable internal/external working relationships

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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