Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 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
We are Looking for a Quality Assurance Specialist to join our team and manage the quality system, primarily focusing on Quality Assurance procedures and work instructions Improvement. The consultant will work closely with our IM Excellence team to analyze document change requests, and ensure compliance with standards. This role requires a mix of technical writing, process evaluation, and continuous improvement activities.
Key Responsibilities:
- Procedure Management: Understand and manage design control procedures, including updates and changes requested by the IM Excellence team and CAPA owners
- Technical Writing:Execute technical writing tasks to update procedures, forms, and templates. Ensure documentation is clear, usable, and compliant with standards.
- Change Control Process: Navigate the change control process within Philips, ensuring all documentation is reviewed validated and approved through the established system.
- Training and Communication: Communicate changes formally through the program and conduct face-to-face training sessions to develop relationships with users and gather feedback.
- Continuous Improvement: Refer to several techniques. Promoting and encouraging QA awareness is a Quality policy,…
- Collaboration: Work closely with cross-functional teams, including engineering, quality assurance, and regulatory compliance, to ensure process improvements are effectively implemented.
- Backlog Management: Manage and prioritize the backlog of procedures and templates, ensuring regular updates and compliance with standards.
- Documentation: Maintain careful records of changes and references within the quality management system.
Qualifications:
- Education: Bachelor's degree in Engineering, Quality Assurance, or a related field.
- Experience: Minimum of 5 years of experience in process improvement, technical writing, and quality management systems within a regulated industry (preferably medical devices).
- Skills
- Understanding of medical devices standards and regulations.
- Strong understanding of design control procedures and quality management systems.
- Excellent technical writing skills.
- Proficiency in Microsoft Office, including Visio.
- Familiarity with SAP or similar configuration management tools.
- Ability to manage multiple tasks and prioritize effectively.
- Strong problem-solving and critical thinking skills.
- Excellent communication and interpersonal skills.
- Preferred Skills:
- Experience with agile incremental development or V-model engineering processes.
- Familiarity with FDA regulations and audit findings.
- Experience in training and development, including face-to-face and virtual sessions.