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For Companies At a Glance
- Tasks: Lead quality compliance and ensure effective quality systems in a dynamic environment.
- Company: Join Abbott, a global leader in healthcare innovation and quality assurance.
- Benefits: Enjoy competitive pay, professional development opportunities, and a supportive work culture.
- Why this job: Make a real impact on product quality and safety while working with a passionate team.
- Qualifications: Bachelor's degree in science and 3-4 years in Quality/Regulatory Affairs preferred.
- Other info: Be part of a company that values integrity and excellence in healthcare.
The predicted salary is between 60000 - 84000 £ per year.
Location: Maidenhead
Pay rate: 70k-75k
Primary Objective of Position
- Responsibility for compliance with Abbott/ ADC Commercial Quality System (QS) and local laws and regulations.
- Ensures Quality System effectiveness through implementation and maintenance of respective procedures and processes.
- Assurance that all relevant requirements are met prior to distributing product in the countries/region incl. product labelling with country regulations.
Major Accountabilities
- Maintains and implements the EMEAP Multisite Integrated Management System (MIMS)/ ADC Commercial Quality System and its compliance at Affiliate/ Regional level according to applicable policies/ procedures and regulations.
- Supervision and control of compliance with quality procedures, incl. implementation, training, and documentation.
- Provides expert quality advice and supports commercial/ business processes regarding quality aspects, incl. e.g. launches and/ or other commercialization projects/ processes.
- Plans and conducts internal audits to verify the effectiveness of the management system.
- Prepares and coordinates external audits.
- Effectively executes key quality processes e.g., Management Reviews, Supplier/ Distributor/ Warehouse Control, CAPA, Promotional Materials, Quality Hold, Document Control and Record Keeping according to established and/or newly developed procedures (e.g. OneAbbott) and supports further developments.
- Performs evaluation, re-evaluation and monitoring of suppliers/ distributors/ warehouses. Evaluate Third-Party Warehouses and Distributors with respective on-site audits (as appropriate).
- Support of medical event reporting and field actions in close cooperation with Product Quality Assurance (PQA), Customer Service, Regulatory Affairs and Vigilance/ Medical Event Group (MEG).
- Supports local complaint handling/ product replacement process and related aspects e.g., with relevant partners/ functional ADC units like PQA and represent respectively within the Affiliate Management Team.
- Prepares/ supports updates to Personnel related documents such as organization chart, job description and training plans.
- Ensures QS training programs in that all relevant employees are trained, and records maintained.
- Initiates, supports, and participates in Quality System improvements and implementation projects.
Education
- Bachelor's degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology).
Background
- Preferably 3-4 years of experience in the Medical Device Industry in the area Quality/ Regulatory Affairs or equivalent experience/ knowledge of regulatory requirements and applicable quality standards.
- Solid technical understanding/ scientific knowledge of products.
- Excellent organization skills; project management experience are a sur-plus.
- Knowledge of PC-based applications, such as Microsoft Office.
- High Proficiency in English language.
Impact of position
- Successful implementation of quality processes and compliance assurance with Abbott's quality procedures and regulations.
- Supports Affiliate/ Regional management to ensure compliance with quality policies, procedures, and requirements regarding commercial/ business processes.
- Quality Representative for Affiliate/ Region.
Quality manager employer: Randstad Delivery (GBS)
Contact Detail:
Randstad Delivery (GBS) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality manager
✨Tip Number 1
Familiarise yourself with the Abbott/ADC Commercial Quality System and local regulations. Understanding these frameworks will not only help you in interviews but also demonstrate your commitment to quality management.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in quality and regulatory affairs. Engaging with them can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare for potential interview questions by reviewing common quality management scenarios. Think about how you would handle audits, compliance issues, and training programs, as these are key aspects of the role.
✨Tip Number 4
Stay updated on the latest trends and changes in quality standards within the medical device industry. This knowledge can set you apart from other candidates and show your proactive approach to professional development.
We think you need these skills to ace Quality manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality management, particularly in the medical device industry. Emphasise your understanding of quality systems and regulatory requirements that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the key responsibilities mentioned in the job description. Explain how your background and skills make you a perfect fit for ensuring compliance with Abbott's quality procedures.
Showcase Relevant Experience: In your application, provide specific examples of past experiences where you successfully implemented quality processes or conducted audits. This will demonstrate your capability to handle the responsibilities of the role.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a quality manager position.
How to prepare for a job interview at Randstad Delivery (GBS)
✨Know the Quality Standards
Familiarise yourself with the specific quality standards and regulations relevant to the medical device industry. Be prepared to discuss how your experience aligns with these standards and how you can ensure compliance in the role.
✨Demonstrate Your Audit Experience
Highlight any experience you have with conducting internal or external audits. Discuss specific examples where you identified issues and implemented solutions, showcasing your ability to maintain quality systems effectively.
✨Showcase Your Technical Knowledge
Be ready to talk about your scientific background and how it applies to the role. Discuss any relevant projects or experiences that demonstrate your understanding of quality processes and product knowledge.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in quality management. Think of examples from your past work where you successfully navigated challenges related to compliance or quality assurance.
