At a Glance
- Tasks: Manage and document change control processes in a regulated medical device environment.
- Company: Join Terumo Aortic, a leader in improving patient outcomes globally.
- Benefits: Collaborative culture, career growth opportunities, and impactful work.
- Other info: Fast-paced environment with a focus on continuous improvement and compliance.
- Why this job: Make a difference in healthcare while developing your skills in a dynamic team.
- Qualifications: Degree in Science or Engineering and experience in Quality Assurance.
The predicted salary is between 40000 - 50000 £ per year.
We are currently recruiting for a Change Control Specialist to join our Quality Assurance team. This role plays a critical part in ensuring the effective management and documentation of change control processes within a highly regulated medical device environment. You will work collaboratively across multiple functions, supporting key quality processes and ensuring compliance with regulatory standards, company policies, and quality requirements.
Key Responsibilities
- Maintain and support the change control process and associated documentation
- Provide guidance and support to departments on developing and implementing change control plans
- Support Quality Engineering activities across R&D, Manufacturing, Engineering and Quality functions
- Prepare and maintain quality system documentation and records
- Generate trending data and reports for management, regulatory bodies and customers
- Drive continuous improvement of change control processes
- Ensure compliance with Quality Management Systems and maintain audit readiness at all times
About You
- You will have a strong background in Quality Assurance within a regulated environment, ideally within the medical device sector.
- Degree in Science or Engineering (or equivalent experience)
- Experience working within a Quality Management System in a regulated industry
- Strong understanding of regulatory standards and QMS requirements
- Excellent analytical, organisational and problem-solving skills
- Strong communication and stakeholder management capability
- Ability to manage priorities and meet deadlines in a fast-paced environment
- Proficient with Microsoft Office and quality systems/tools
Why Join Us
At Terumo Aortic, you’ll be part of a collaborative and innovative organisation committed to improving patient outcomes worldwide. You will have the opportunity to work across global teams, contribute to meaningful change, and grow your career within a regulated and high-impact environment.
Change Control Specialist in Erskine employer: Terumo Aortic
At Terumo Aortic, we pride ourselves on fostering a collaborative and innovative work culture that prioritises employee growth and development. As a Change Control Specialist, you will be integral to our mission of improving patient outcomes, with access to global teams and opportunities for continuous improvement in a highly regulated medical device environment. Join us to make a meaningful impact while enjoying a supportive atmosphere that values compliance and quality excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Change Control Specialist in Erskine
✨Tip Number 1
Network like a pro! Reach out to current employees at Terumo Aortic on LinkedIn or through industry events. A friendly chat can give you insider info and maybe even a referral!
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of change control processes and regulatory standards. We want you to show off your expertise and how it aligns with the role!
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. This will help you articulate your experiences in a structured way, making it easier for interviewers to see your fit for the Change Control Specialist role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed and shows your genuine interest in joining our Quality Assurance team.
We think you need these skills to ace Change Control Specialist in Erskine
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in Quality Assurance, especially within regulated environments. We want to see how your background aligns with the Change Control Specialist role, so don’t be shy about showcasing relevant skills and achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality management in the medical device sector. We love seeing candidates who can articulate their motivation and how they can contribute to our team.
Showcase Your Analytical Skills:Since this role involves generating reports and trending data, make sure to highlight any experience you have with data analysis or quality systems. We’re looking for someone who can demonstrate strong analytical capabilities, so give us examples!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details about the role and our company culture there!
How to prepare for a job interview at Terumo Aortic
✨Know Your Change Control Processes
Make sure you brush up on the change control processes specific to the medical device industry. Be ready to discuss how you've managed or supported these processes in your previous roles, as this will show your understanding of the regulatory environment.
✨Showcase Your Quality Assurance Experience
Prepare examples from your past work that highlight your experience in Quality Assurance. Focus on situations where you ensured compliance with regulatory standards and how you contributed to maintaining audit readiness.
✨Demonstrate Strong Communication Skills
Since this role involves collaboration across multiple functions, practice articulating your thoughts clearly. Think of examples where you successfully communicated complex information to stakeholders, as this will be crucial for the position.
✨Be Ready for Problem-Solving Scenarios
Expect questions that assess your analytical and problem-solving skills. Prepare to discuss specific challenges you've faced in a regulated environment and how you approached them, showcasing your ability to manage priorities effectively.
