Quality Assurance Lead

🔎 Title: Manufacturing Quality Manager

📍 Location: Frankfurt, Hessen, Germany (onsite)

✉️ Contact: frankie@elemed.eu

🔸 The Company

Are you someone who has solid GMP experience in either medical devices or pharmaceutical industries? Do you enjoy taking leadership and ownership of your QA processes and implementing them on the production floor? Do you enjoy leading a small team of QA specialists? Do you like being a creative, solutions-oriented QA-professional?

This American company is a manufacturer of complex medical devices. They are at a really exciting point of implementing new QA processes at their German manufacturing site and would like an experienced QA person with team leadership experience to work with the Manufacturing Site Leader to streamline existing processes.

Building a strong Quality culture has always been important for this company and the Global Department Leader, which is why they have identified areas of improvement at the German site which will be critical for their European market success as the only European hub.

🔹 The Opportunity

With big goals set ahead of them, they are looking for a seasoned QA-manager to join the team and support them in streamlining all Quality Assurance processes particularly on the production floor. The role also requires someone who can collaborate well inter-culturally between German teams and American teams.

As the Manufacturing Quality Manager, you will be responsible for assessing and auditing the existing QA/QC and Quality Operations processes and identifying how it can be improved and optimized. You will also engage with CAPAs, closing non-conformities, and be the front spokesperson for auditors from Notified Bodies. It is important that you work well with the German Site Leader and you will report into Senior Quality Director in the USA.

The company will also provide you with training on their complex medical devices and new ISO standards to add to your skillset!

🔸 Responsibilities:

• Take ownership of new QA-processes and implement them to the production line
• Be an solutions-oriented advisor for American HQ and report back on Germany’s operations and needs
• Be a creative, problem-solving consultant for the German local team on all aspects of quality
• Identify gaps and/or improvements within the existing or newly-created QA processes, and create a strategy to drive improvements and implement the new processes
• Help and influence the company’s European strategy and success through good quality measures and processes
• Generate, review and edit SOPs, and other applicable documentations
• Undertake internal audits and take responsibility for the communication between the company and critical partners relating to quality topics
• Redesign, build and drive change in quality excellence and processes
• Drive a culture of continuous improvement
• ​Manage review meetings and other processes related to Non-conformances, CAPAs, Customer Complaints, Deviations as neededP
• lan and execute Quality training

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� Your qualifications:M

• inimum 7 years of Quality Assurance experience in the medical device or pharmaceutical industryS
• trong experience in Auditing, GMP, closing CAPAs and Non-Conformities, or Validation & VerificationF
• luent English and German

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️ If you are interested in this exciting role, please send your application directly to frankie@elemed.eu

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� Would you like to find out more about our open opportunities? Visit https://www.elemed.eu/vacancies/

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lease note: Only candidates meeting the requirements set out in the role profile above, will be considered in the application process. D

ue to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful. _

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� Elemed is Europe’s leading MedTech technical recruiter. We serve within the Medical device, diagnostic and combination device arena, working with Managers up to VP of Quality and Regulatory. Our team helps medical device experts of today become leaders of tomorrow.

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� We won Best International Recruitment Agency at the Recruiter Awards 2021.A

t Elemed, we recruit exceptional people that solve regulatory and compliance problems, so patients can have access to safe, innovative and life-changing Medical Devices.

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️ We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.