Agfa HealthCare is a leading medical imaging and information management company, providing software solutions for hospitals worldwide. With Agfa HealthCare products, hospitals can provide care for patients that is both more efficient and more effective. Using the latest technologies, Agfa's solutions are revolutionizing how patients are diagnosed and treated, ultimately saving lives. As a pioneer in our field, we take great pride in our people and our work to modernize the delivery of healthcare.
We offer a rewarding career developing technology in a field that impacts lives, the opportunity to work with a talented, committed team of individuals, and a competitive compensation and benefits package.
The Cardiovascular QARA Team is in search for a Post Market QARA Analyst
Basic Purpose
As a Post-Market QA Analyst you are responsible for managing complaints escalated for mission critical products and systems in the medical devices product line. You will be researching and responding to often-times complex complaints received from customers and various regulatory agencies.
This position may be based out of the following location(s) and surrounding area:
Westerly, Rhode Island
Responsibilities:
As a Post-Market QA Analyst you are responsible for managing complaints escalated for mission critical products and systems in the medical devices product line. You will be researching and responding to often-times complex complaints received from customers and various regulatory agencies. You will ensure that results and relevant documentation are sent to the appropriate parties along with a timely, accurate and complete written response. You will work on cross-functional teams to address product issues, define and implement effective corrective actions and monitor post-implementation effectiveness. You are seen as an internal consultant providing guidance on the evaluation and resolution of escalated complaints by working with our Business Unit Managers and other Agfa employees.
Other deliverables in this role include:
•Be the subject matter expert and process owner for complaint management for the global Quality Management System as it relates to Agfa development sites.
•Conduct co-ordination of escalated issues and complaints in compliance with global procedures.
•Analyze, identify and report complaint trends to designated managers and to participants in appropriate meetings & reviews.
•Participate in Health Hazard Evaluations on escalated complaints which may represent risks to patient healthcare.
•Work with other business partners and stakeholders to: investigate the root cause of the problem, implement corrections, corrective actions and preventive actions (CAPA), and to provide follow-up to ensure effective solutions.
•Work with other members of the QARA group to ensure that those complaints requiring recalls or reports to regulatory authorities are appropriately identified and escalated.
•Provide support to business partners as they implement solutions.
•Identify complaint trends, performing routine analysis and generating periodic management complaint trending reports using analytical software/databases.
Qualifications:
You must have gained your experience in a regulated industry - preferably medical device, pharmaceutical or related - in project management, analyst, technical support, quality management, or quality assurance position(s). Ito developing strong skills in problem solving and project management, you have also developed the following:
•A familiarity with ERP/MRP, MRS, and quality software systems (e.g., complaint, document control, etc.)
•A familiarity with international regulations and standards pertaining to medical devices development and deployment; familiarity with ISO 9001 (or ISO 14971) and FDA QSR, ability to interpret and work with regulations and standards
•An exposure to risk management processes
•An ability to work independently towards deadlines and strong attention to detail
•A sense of comfort in with working with Business partners to investigate complaints
•A knowledge of software development methodologies and practices