R&D Quality Manager (Medical Devices and/or Combination Products)
R&D Quality Manager (Medical Devices and/or Combination Products)

R&D Quality Manager (Medical Devices and/or Combination Products)

Cambridge Full-Time 36000 - 60000 Β£ / year (est.) No home office possible
Sandoz

At a Glance

  • Tasks: Manage quality and compliance for R&D in medical devices and combination products.
  • Company: Join Sandoz, a leader in pharmaceutical manufacturing focused on innovation.
  • Benefits: Enjoy full-time employment with opportunities for continuous learning and professional growth.
  • Other info: This role offers a chance to lead quality improvement initiatives in a dynamic environment.
  • Why this job: Be part of impactful projects that improve health outcomes and drive quality initiatives.
  • Qualifications: Experience in project management, regulatory compliance, and quality assurance is essential.

The predicted salary is between 36000 - 60000 Β£ per year.

This role involves supporting quality management, regulatory compliance, and continuous improvement initiatives within the R&D department for medical devices and combination products.

Key Responsibilities

  • Maintain regulatory files for inspections and assist with inspection management.
  • Generate and review quality and safety plans for clinical programs.
  • Support quality performance initiatives, including risk management and health authority reporting.
  • Identify quality issues, investigate root causes, and develop CAPAs.
  • Assist in remediation of deviations and monitor corrective actions.
  • Manage quality aspects of projects, including third-party activities, equipment, and documentation.
  • Review and approve quality deliverables to ensure compliance.
  • Report technical complaints, adverse events, and manage sample distribution where applicable.

Major Accountabilities

  • Ensure quality systems are maintained and risks are mitigated.
  • Lead quality improvement initiatives and ensure regulatory compliance.
  • Identify training needs based on audit and assessment results.

Minimum Requirements

  • Work Experience: Functional breadth, critical negotiations, project management, cross-boundary collaboration.
  • Skills: Agility, analytical skills, audit management, business partnering, change control, continuous learning, health authorities knowledge, influencing skills, CAPA knowledge, QA, risk management, root cause analysis, self-awareness, Six Sigma, SOP, technological expertise.
  • Languages: English

Additional Details

  • Seniority level: Mid-Senior level
  • Employment type: Full-time
  • Job function: Research, Analyst, and IT
  • Industry: Pharmaceutical Manufacturing

R&D Quality Manager (Medical Devices and/or Combination Products) employer: Sandoz

Sandoz is an exceptional employer that prioritises innovation and quality in the pharmaceutical manufacturing sector. With a strong commitment to employee development, we offer robust training programmes and opportunities for career advancement, all within a collaborative and inclusive work culture. Located in a dynamic environment, our team enjoys the unique advantage of contributing to meaningful projects that enhance patient care while being supported by a dedicated leadership team focused on continuous improvement.
Sandoz

Contact Detail:

Sandoz Recruiting Team

StudySmarter Expert Advice 🀫

We think this is how you could land R&D Quality Manager (Medical Devices and/or Combination Products)

✨Tip Number 1

Familiarise yourself with the latest regulations and standards in the medical devices sector. This knowledge will not only help you during interviews but also demonstrate your commitment to compliance and quality management.

✨Tip Number 2

Network with professionals in the R&D and quality management fields. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the industry.

✨Tip Number 3

Prepare to discuss specific examples of how you've successfully managed quality improvement initiatives in past roles. Highlight your experience with CAPAs and root cause analysis, as these are crucial for the role.

✨Tip Number 4

Showcase your analytical skills by being ready to discuss how you've used data to drive decisions in quality management. Being able to articulate your thought process will set you apart from other candidates.

We think you need these skills to ace R&D Quality Manager (Medical Devices and/or Combination Products)

Regulatory Compliance
Quality Management Systems
Root Cause Analysis
Corrective and Preventive Actions (CAPA)
Risk Management
Audit Management
Project Management
Analytical Skills
Change Control
Health Authority Knowledge
Continuous Improvement
Technical Expertise in Medical Devices
Business Partnering
Influencing Skills
Self-Awareness

Some tips for your application 🫑

Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and requirements of the R&D Quality Manager position. Familiarise yourself with quality management, regulatory compliance, and continuous improvement initiatives specific to medical devices and combination products.

Tailor Your CV: Customise your CV to highlight relevant experience in quality management, project management, and regulatory compliance. Emphasise skills such as root cause analysis, CAPA knowledge, and any experience with health authority requirements.

Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality management in the pharmaceutical industry. Mention specific examples of how you've led quality improvement initiatives or managed regulatory files in previous roles.

Highlight Relevant Skills: In your application, be sure to highlight key skills mentioned in the job description, such as analytical skills, audit management, and risk management. Use specific examples to demonstrate your proficiency in these areas.

How to prepare for a job interview at Sandoz

✨Understand Regulatory Requirements

Familiarise yourself with the specific regulatory requirements for medical devices and combination products. Be prepared to discuss how you have managed regulatory files and ensured compliance in your previous roles.

✨Showcase Your Analytical Skills

Highlight your experience with root cause analysis and CAPA development. Prepare examples of how you've identified quality issues and implemented corrective actions in past projects.

✨Demonstrate Continuous Improvement Mindset

Discuss your involvement in quality performance initiatives and how you've contributed to risk management. Share specific instances where you've led or participated in quality improvement projects.

✨Prepare for Scenario-Based Questions

Expect scenario-based questions that assess your problem-solving skills. Think of situations where you've had to manage third-party activities or handle technical complaints, and be ready to explain your approach.

R&D Quality Manager (Medical Devices and/or Combination Products)
Sandoz
Location: Cambridge

Land your dream job quicker with Premium

You’re marked as a top applicant with our partner companies
Individual CV and cover letter feedback including tailoring to specific job roles
Be among the first applications for new jobs with our AI application
1:1 support and career advice from our career coaches
Go Premium

Money-back if you don't land a job in 6-months

>