At a Glance
- Tasks: Support the Nonconformance and CAPA process to ensure compliance with quality standards.
- Company: Join a leading medical device company focused on quality and innovation.
- Benefits: Competitive salary, travel opportunities, and professional growth in a dynamic environment.
- Other info: Opportunity for travel and collaboration across teams globally.
- Why this job: Make a real impact in healthcare by ensuring product quality and safety.
- Qualifications: Bachelor's degree and 5 years in Non-Conformance/CAPA processes required.
The predicted salary is between 50000 - 65000 £ per year.
The Remediation CAPA Engineer supports the execution and remediation of the Nonconformance (NC) and CAPA process under the direction of Quality Systems leadership. This role focuses on ensuring compliance with applicable Quality System requirements, including FDA 21 CFR Part 820, ISO 13485:2016, MDSAP, and internal procedures, by assisting with the review, correction, and progression of NC and CAPA records. The position supports remediation activities by preparing and updating NC/CAPA records, supporting data analysis, assisting with TrackWise system activities, and helping address overdue, high-risk, or inspection-critical records. The role works cross-functionally and across sites to support timely, consistent, and compliant execution of NC/CAPA remediation actions.
Responsibilities
- Supports remediation and execution of NC and CAPA activities in accordance with established procedures and global regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485).
- Reviews NC and CAPA records for completeness, accuracy, and procedural compliance, and supports timely routing and progression of records.
- Provides hands-on support to NC/CAPA Owners and Leads on record content, remediation expectations, and appropriate use of the NC/CAPA system.
- Prepares metrics, reports, and data summaries to support oversight by Quality Systems leadership and CAPA Review Boards.
- Supports cross-functional teams with remediation of high-priority, overdue, or inspection-critical NC and CAPA records.
- Participates in NC/CAPA escalation and board meetings in a supporting role, including status updates and follow-up of assigned actions.
- Assists with NC/CAPA TrackWise system activities, including data clean-up, user support, and validation tasks (e.g., user acceptance testing).
- Demonstrates comprehensive understanding of mechanism and key components in the Quality Management System.
- Maintains knowledge of regulations and standards in the quality management system for Medical Devices (e.g., ISO 13485).
- Applies effective problem solving and data analysis (trending) with attention to detail.
- Knowledge of statistical techniques and their application.
- Willingness to adhere to confidentiality principles.
- Comfortable working in a highly regulated, fast-paced environment.
- Effective and proactive communication, particularly in a remote-working situation.
Qualifications/Education
- Bachelor's Degree in Science, Engineering, or related discipline.
- Minimum 5 years supporting a Non-Conformance/CAPA process in the medical device or healthcare industry.
- Expert skill level utilizing TrackWise.
- Knowledge of ISO 13485:2016, 21 CFR Part 820, and MDSAP.
- Ability to deal with difficult situations with tact and professionalism.
- Effective written and oral communication skills and ability to work with employees at all levels of the organization.
- Demonstrated problem solving and troubleshooting skills.
- Ability to work without close supervision and produce quality work.
- Strong computer skills: MS Office (Outlook, PowerPoint, Word, Excel), Microsoft Teams, and Adobe Acrobat Pro.
Other
- Travel: 30-50% domestic/international travel may be required; this may include overnight travel.
- Languages: Speaking and writing/reading in English and Spanish.
Remediation CAPA Engineer in City of Westminster employer: ConvaTec Inc
As a Remediation CAPA Engineer, you will thrive in a dynamic and supportive work environment that prioritises compliance and quality in the medical device industry. Our company fosters a culture of collaboration and continuous improvement, offering ample opportunities for professional growth and development while ensuring a healthy work-life balance. With a commitment to innovation and excellence, we provide our employees with the tools and resources needed to succeed, making us an exceptional employer in this field.
StudySmarter Expert Advice🤫
We think this is how you could land Remediation CAPA Engineer in City of Westminster
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like ConvaTec Inc looking for candidates who are engaged and informed.
We think you need these skills to ace Remediation CAPA Engineer in City of Westminster
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at ConvaTec Inc. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at ConvaTec Inc
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with ConvaTec Inc’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
