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- Tasks: Ensure compliance with ISO 9001 and maintain quality management systems.
- Company: Leading medical device company with a focus on quality assurance.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a strong emphasis on continuous improvement.
- Why this job: Join a dynamic team and make a real impact on quality standards in healthcare.
- Qualifications: BSc degree and 2+ years of relevant QA experience required.
The predicted salary is between 40000 - 50000 £ per year.
Locations: Newbury, United Kingdom
Time Type: Full time
Posted on: Posted Today
Job Requisition ID: R564811
Work Flexibility: Hybrid
Position Summary
Develops and applies sound knowledge and understanding of the QA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation. Responsible for developing and maintaining the QMS and ensuring compliance to the ISO9001 standard.
Key Activities & Accountabilities
- Along with the QA Associate Manager and Lead Specialist, responsible for ensuring compliance with the ISO 9001 standard across UK&BNN sites.
- Develop and maintain UK&BNN QMS and documentation system to ensure sites operate within approved Corporate and Regional EMEA process and procedures.
- Ensure quality records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records.
- Support annual Management Reviews of the Quality System to ensure and monitor its suitability, adequacy and effectiveness.
- Support a program of Internal Quality Audits covering all processes.
- Support continual improvements of the QMS, ensuring that evidence of corrective and preventive actions taken are recorded and reviewed. Work with process owners to ensure timely CAPA investigation and closure.
- Assist in creation of a QMS training program. Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Provide update training as necessary.
- Analyse data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
- Support departmental process owners to identify, implement and document improvement opportunities.
- Assist in creation of quality objectives for RAQA and non-RAQA departments.
- Report to management on the performance of the QMS and any need for improvement.
Education
BSc degree in relevant field. Advanced Degree preferred.
Experience
2+ years relevant experience.
Knowledge/Competencies
- Project support and time management skills, writing, coordination, and execution of more complex QA items.
- Demonstrated knowledge and application of quality requirements including ISO 9001.
- Some technical knowledge of medical device quality requirements.
- Ability to develop influence across the organization.
- Coordinate and support technical and scientific QA activities.
- Ability to act under minimal supervision and take decision in the relevant area of competence.
- Clearly conveys information to peers, supervisors, and other stakeholders across the EMEA organisation, Design Divisions and third-party distributors.
- Attend meetings with regulatory agencies, internal and external audits and other stakeholders.
- Prepares briefings and other information documents.
- Seeks out diverse ideas, opinions, and insights, and applies them in the workplace.
- Connects and relates well with people who think and act differently than oneself.
- Embraces scrutiny and accepts feedback as opportunity to learn and improve.
- Preparation of QA metrics for reporting purposes.
- High attention to detail and process consciousness.
- Strong IT skills, including Microsoft Office.
- Fluent in English (+ local language where applicable).
Travel Percentage: 10%
Senior Specialist QA in Newbury employer: Stryker Corporation
Contact Detail:
Stryker Corporation Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Specialist QA in Newbury
✨Tip Number 1
Network like a pro! Reach out to your connections in the QA field, attend industry events, and join relevant online groups. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its QA processes. Familiarise yourself with ISO 9001 standards and be ready to discuss how your experience aligns with their needs. Confidence is key!
✨Tip Number 3
Showcase your skills through practical examples. When discussing your experience, highlight specific projects where you improved quality systems or led audits. This will demonstrate your hands-on expertise.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Senior Specialist QA in Newbury
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the Senior Specialist QA role. Highlight your knowledge of ISO 9001 and any relevant QA frameworks to show us you’re the right fit!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance and how your background aligns with our needs. Don’t forget to mention your experience with QMS and compliance!
Showcase Your Achievements: When detailing your experience, focus on specific achievements that demonstrate your impact in previous roles. We love seeing how you’ve contributed to quality improvements or successful audits!
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s super easy, and we can’t wait to see your application come through!
How to prepare for a job interview at Stryker Corporation
✨Know Your QA Frameworks
Make sure you brush up on your knowledge of QA frameworks, especially ISO 9001. Be ready to discuss how you've applied these standards in your previous roles and how they relate to the position you're applying for.
✨Showcase Your Experience
Prepare specific examples from your past work that demonstrate your experience with quality management systems and compliance. Highlight any projects where you successfully implemented improvements or managed audits.
✨Communicate Clearly
Practice conveying complex information in a straightforward manner. Since you'll be interacting with various stakeholders, being able to clearly articulate your thoughts will be crucial during the interview.
✨Embrace Feedback
Be open about your willingness to accept feedback and learn from it. Share instances where you've received constructive criticism and how it helped you improve your processes or skills.