Quality and Regulatory

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:   

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you! 

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.   

As you know, every person is different and so is every role in a company.  That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience. 
We look forward to meeting you!

Job description

Key Responsibilities:

• Provide experience, infrastructure, and documentation support to prove compliance with applicable international requirements, such as product safety, EMC, and RoHS, to obtain relevant certifications and declarations.
• Perform root cause analysis and corrective actions at third-party supplier facilities to prevent the delivery of defective products.
• Collaborate with suppliers and manufacturing teams to ensure quality standards are met and maintained.
• Execute independent procedures to verify that products, services, or systems meet requirements and specifications and fulfill their intended purposes.
• Implement inspection and structured testing as measures of quality assurance to prevent mistakes and defects in manufactured products.
• Maintain systematic procedures to proactively collect and review experience gained from the installed base, market, or service to identify any need for immediate corrective and preventive actions (CAPAs).

Technical Requirements:

1. Regulatory Compliance:

   • Experience in regulated environments and interactions with regulatory agencies.
   • Knowledge of global medical device regulations and product documentation, including FDA, EU Medical Device Regulations, ISO 13485, ISO 27001, FDA, IEC62304, IEC60601, and other relevant standards.

2. Supplier Quality Engineering:

   • Ability to perform root cause analysis and corrective actions at third-party supplier facilities.
   • Experience in supplier quality engineering, manufacturing engineering, and IQ/OQ/PQ processes.

3. Quality Assurance:

   • Ability to execute independent procedures to ensure products meet requirements and specifications.
   • Experience in implementing inspection and structured testing as measures of quality assurance.
   • Ability to prevent mistakes and defects in manufactured products and avoid problems when delivering products or services to customers.

4. Systematic Procedure Maintenance:

   • Ability to maintain up-to-date systematic procedures to proactively collect and review experience gained from the installed base, market, or service.
   • Ensure the timely application of necessary corrective and preventive actions (CAPAs).