At a Glance
- Tasks: Ensure quality compliance with ISO and FDA standards while supporting audits and document control.
- Company: Join a leading company committed to quality and innovation in healthcare.
- Benefits: Gain valuable experience, competitive salary, and opportunities for professional growth.
- Other info: Inclusive workplace that values diversity and offers career advancement.
- Why this job: Make a difference in healthcare by ensuring product quality and safety.
- Qualifications: 3 years of administration experience and knowledge of quality management systems.
The predicted salary is between 35000 - 45000 £ per year.
We are currently recruiting for a Quality Specialist. This is an excellent opportunity to join the business at a skilled professional level.
About the Role
The Quality Specialist will be responsible for assisting in administration of the quality functions on site to assure adherence to ISO 13485, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions and site record retention. In addition, the Quality Specialist will assist in audit coordination and support validation and risk management activities where appropriate.
Responsibilities
- Process document control transactions.
- Review DHRs and support batch record release.
- Support record retention practices within the site.
- Coordinate site calibration activities and recordkeeping.
- Coordinate site inspection activities and recordkeeping.
- Support internal and external auditing processes.
- Support targeted Lean activities.
- Complete other duties as assigned.
Required Experience
- Administration – 3 years experience
- Document control
- QMS experience
Skills
- Teamwork: Collaborates with others and works in a professional manner to support team actions.
- Results: Effectively manages work tasks, details-oriented, strives for continuous improvement, analyzes technical issues, and copes with change and shifting priorities.
- Communication: Constructs clear written communication and keeps manager and co-workers informed.
- Job Knowledge: PC experience and working familiarity with common desktop applications including Excel and Word.
Equal Opportunities
STERIS plc provides employment and advancement opportunities without regard to age, disability, gender reassignment, marriage or civil partnership, pregnancy and maternity, race, religion/belief, sex (gender), sexual orientation or any other legally protected characteristic as defined by UK employment law. The Company bases all employment decisions on merit, qualifications, skills, and abilities with the intention that the best candidate is selected for each position.
Quality Compliance Specialist – ISO & FDA in Syston employer: STERIS
Joining STERIS plc as a Quality Compliance Specialist offers you the chance to be part of a dynamic team dedicated to maintaining high standards in quality management. With a strong commitment to employee development, we provide ample opportunities for professional growth and continuous improvement within a supportive work culture. Located in a vibrant area, our company values diversity and inclusion, ensuring that every employee feels valued and empowered to contribute to our mission.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Compliance Specialist – ISO & FDA in Syston
✨Tip Number 1
Network like a pro! Reach out to your connections in the quality compliance field, especially those familiar with ISO and FDA standards. 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 document control and QMS. We recommend practising common interview questions related to quality compliance and having examples ready that showcase your teamwork and results-driven mindset.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at StudySmarter.
We think you need these skills to ace Quality Compliance Specialist – ISO & FDA in Syston
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Compliance Specialist role. Highlight your experience with ISO standards and document control, as these are key for us. Use specific examples that showcase your skills in quality management systems.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Explain why you're passionate about quality compliance and how your background aligns with our needs. Keep it concise but engaging, and don’t forget to mention your teamwork and communication skills.
Showcase Relevant Experience:When detailing your work history, focus on roles where you’ve dealt with regulatory standards like FDA or ISO. We want to see how you've contributed to quality assurance in previous positions, so be specific about your achievements!
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 role. Plus, it shows you’re proactive and keen to join our team!
How to prepare for a job interview at STERIS
✨Know Your Standards
Familiarise yourself with ISO 13485 and FDA regulations before the interview. Being able to discuss these standards confidently will show that you understand the core of the role and are serious about compliance.
✨Showcase Your Document Control Skills
Prepare examples from your past experience where you successfully managed document control transactions. Highlight any specific tools or systems you've used, as this will demonstrate your practical knowledge in a key area of the job.
✨Emphasise Teamwork and Communication
Think of instances where you collaborated effectively with others or communicated complex information clearly. This is crucial for a Quality Specialist, so be ready to share these stories during your interview.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving skills and ability to handle shifting priorities. Prepare by thinking through potential scenarios related to quality compliance and how you would approach them.
