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Formed in 2019 through the merger of Sivantos and Widex, WS Audiology combines over 140 years of experience in pioneering better solutions to help people with hearing loss. With a passion for impact, our 11.000 employees are committed to achieving our purpose: wonderful sound for all.
With brands like Signia, Widex, Audio Service, Rexton and Vibe, and with diverse assets across wholesale retail, online, managed care and diagnostic solutions, we are active in over 125 markets. Going beyond together, we achieve annual revenues of around EUR 2 billion.
As a global leader, our ambition is to unlock human potential by making wonderful sound part of everyone’s life.
Learn about us on www.wsa.com and take a look at why you will love working here:
As PMS Officer (m/f/d) you will be part of the global Quality team, more specifically the QA Customer Service & Sales team focused on customer/consumer related processes. The team consists of various team members managing customer complaints, device investigations or other related tasks, these colleagues are located in various areas of the world.
As Global Post Market Surveillance Officer (m/f/d) you will be managing our post market surveillance process as per internal requirements and any applicable regulatory requirements for medical device.
You will be tracking, trending and monitoring product related data available globally (Repair, Customer Dissatisfaction, Complaints, apps feedback, cyber-security etc.) to increase visibility and tracking of issues or emerging issues within the markets.
You will establish strong partnership with colleagues in Quality, R&D, Marketing and other counterparts in identifying and implementing product related improvements; these colleagues may be located in various areas of the world.
You will report to our Director Quality - Customer Service & Sales.
In this role you will have the following responsibilities:
Tracking and trending of product related data available globally (Repair, Customer Dissatisfaction, Complaints, etc.) to increase visibility and tracking of issues or emerging issues within the markets.
Conduct National Competent Authorities Database query to identify reports associated with Hearing Instruments and Accessories.
Preparation and Moderation of PMS meetings to review product-related information/feedback from the markets and determine/track applicable follow up/corrective actions.
Ensure creation and maintenance of the Post Market Surveillance relevant documentation for WSA (Post Market Surveillance (PMS) Report, Periodic Safety Update Report (PSUR) and PMS Data Review presentation)
Act as central point of contact for WSA for all topics related to Post Market Surveillance and tracking/trending of product related quality issues.
Continuously identify, develop and implement process improvements related to Post Market Surveillance
General Quality Support (Local):
Part of the local quality team and assist/participate with internal and external audits and associated preparation.
Assist in implementing and maintaining local QMS, training system and doc control related procedures.
Measures performance against process requirements.
Act as SME in Internal/External audit as subject matter expert
We expect you to have great data analytics skills, good understanding of the regulations related to medical devices and great interpersonal skills. Additionally, you are a strong communicator that knows when to insist and when to accept a compromise. You are a team player and have a good sense of urgency. You also challenge the status quo and are a good communicator.
You most likely fit the following profile:
Bachelor degree in Engineering, Science, Analytics, Business Administration or other related field
At least 5 years’ experience in Quality, Quality Management Systems within regulated industry; preferably medical devices.
Experience in customer service, complaint handling or post market surveillance related processes.
Knowledge of Quality Standards and Quality Systems Requirements in Medical Device Industry worldwide (e.g. ISO 13485, CFR/GMP, MDD, MDR, MPG)
Experience working with colleagues overseas in US, Europe and Asia
Knowledge of Post Market Surveillance, Complaint Handling standards and regulations
Our corporate language is English, so you need to be confident in English, both verbally and in writing.
What we offer
We are driven by innovation and development so working with us is a constant learning curve. You will be located in our site in Erlangen, Germany with dynamic and progressive colleagues, who are highly skilled and empathetic.
We offer flexible working times & opportunities for working from home. You can always get free coffee at the office. We are part of the IG Metall tariff agreement offering attractive compensation and futher benefits like contributions to the company pension plan or child-care.
Join WS Audiology
If this opportunity sounds interesting to you, please submit your application stating your earliest starting date and your salary expectations and we will get back to you as soon as possible.