Quality Systems Engineer - ISO 13485 & Change Control Lead in Penicuik

Quality Systems Engineer - ISO 13485 & Change Control Lead in Penicuik

Penicuik Full-Time 35000 - 45000 € / year (est.) Home office (partial)
Alivedx

At a Glance

  • Tasks: Manage document control and oversee change control processes in a dynamic environment.
  • Company: Join AliveDx, a leader in quality and regulatory affairs in the medical device sector.
  • Benefits: Enjoy flexible working options, private medical cover, and extra annual leave.
  • Why this job: Make a real impact in quality assurance while advancing your career in a compliant environment.
  • Qualifications: Bachelor's degree and 3 years of experience in quality assurance required.

The predicted salary is between 35000 - 45000 € per year.

AliveDx in Penicuik is seeking a Quality Systems Engineer for its Quality and Regulatory Affairs team. This full-time position involves managing document control, overseeing change control processes, and conducting failure investigations.

Ideal candidates will have:

  • A Bachelor's degree in a related field
  • At least 3 years of experience in a quality assurance role within a compliant environment like medical devices

Flexible working options and a range of benefits are offered, including private medical cover and additional annual leave.

Quality Systems Engineer - ISO 13485 & Change Control Lead in Penicuik employer: Alivedx

AliveDx is an exceptional employer located in Penicuik, offering a dynamic work environment that fosters innovation and professional growth. With flexible working options, comprehensive benefits including private medical cover, and a commitment to employee development, we ensure our team members thrive both personally and professionally while contributing to the vital field of medical devices.

Alivedx

Contact Detail:

Alivedx Recruiting Team

StudySmarter Expert Advice🤫

We think this is how you could land Quality Systems Engineer - ISO 13485 & Change Control Lead in Penicuik

Tip Number 1

Network like a pro! Reach out to professionals in the quality assurance field, especially those with experience in ISO 13485. A friendly chat can lead to insider info about job openings or even a referral.

Tip Number 2

Prepare for interviews by brushing up on your knowledge of change control processes and failure investigations. We recommend practising common interview questions related to quality systems to show you're the right fit for the role.

Tip Number 3

Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your interest in the position. It keeps you fresh in their minds!

Tip Number 4

Apply through our website for the best chance at landing that Quality Systems Engineer role. We make it easy for you to showcase your skills and experience directly to the hiring team!

We think you need these skills to ace Quality Systems Engineer - ISO 13485 & Change Control Lead in Penicuik

Document Control Management
Change Control Processes
Failure Investigation
Quality Assurance
ISO 13485
Regulatory Affairs Knowledge
Experience in Medical Devices

Some tips for your application 🫡

Tailor Your CV:Make sure your CV highlights your experience in quality assurance, especially in compliant environments like medical devices. We want to see how your background aligns with the role of Quality Systems Engineer.

Showcase Relevant Experience:When writing your cover letter, focus on your experience with document control and change control processes. We love to see specific examples that demonstrate your skills and achievements in these areas.

Be Clear and Concise:Keep your application clear and to the point. We appreciate well-structured documents that are easy to read. Avoid jargon unless it’s relevant to the role, and make sure to proofread for any typos!

Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the Quality Systems Engineer position at AliveDx.

How to prepare for a job interview at Alivedx

Know Your ISO 13485 Inside Out

Make sure you brush up on ISO 13485 standards before the interview. Be ready to discuss how you've applied these standards in your previous roles, especially in managing document control and change control processes.

Showcase Your Problem-Solving Skills

Prepare examples of past failure investigations you've conducted. Highlight your analytical skills and how you approached each situation to ensure compliance and improve quality systems.

Understand the Company Culture

Research AliveDx and their values. Knowing about their commitment to quality and regulatory affairs will help you align your answers with what they’re looking for, showing that you’re a great fit for their team.

Ask Insightful Questions

Prepare thoughtful questions about the role and the team dynamics. This not only shows your interest but also helps you gauge if the company is the right fit for you, especially regarding flexible working options and benefits.