At a Glance
- Tasks: Ensure top-notch quality in manufacturing and lead investigations on discrepancies.
- Company: Join a leading company in the Medical Device/Pharmaceutical industry.
- Benefits: Generous bonuses, flexible vacation, health plans, and employee discounts.
- Other info: Enjoy hybrid working, mentorship, and a culture of inclusion and belonging.
- Why this job: Make a real impact on product quality and compliance in a dynamic environment.
- Qualifications: Degree in relevant field or 3 years' experience in quality roles.
The predicted salary is between 35000 - 45000 € per year.
A member of the Quality control team, the job holder performs a vital role in maintaining the highest levels of quality & compliance. The job holder is responsible for front line Quality support ensuring the manufacturing value stream applies high levels of quality. Responsible for first pass quality review of documentation and records and leads the investigation and disposition of discrepant materials.
What will you be doing?
- Acts as the operational quality partner to operations value stream structure.
- Support and deputise for the Value Stream Quality Engineer.
- Leads the timely review and release of intermediate and finished product documentation.
- Archiving of quality documentation as per site procedures.
- Generation of COA/COC as needed for manufactured product.
- Follow documented processes to ensure that product disposition and release of compliant product are performed within agreed lead-times.
- Acts as SME in audits for front line quality issues.
- Raw material incoming inspection / sampling.
- Leads the containment, investigation and disposition of defective intermediate and finished products, including the management of NC’s and CAPA’s as needed.
- To assist in Change Control activities ensuring outputs are correctly translated into procedures and are communicated.
- Assessment of Quality issues, containment of the issue and determine level of escalation within the Quality management system.
- When required, provide cover to review and release final products (electronic release to market).
- Coordinate and manage raw material concession and shelf-life expiry extension requests ensuring compliance with QMS and CAPA system.
What will you need to be successful?
- Educated to degree level with a minimum of 2.2 Hons or at least 3 years’ experience working within a quality related role within Medical Device / Pharmaceutical Industry e.g. ISO 9001, ISO 13485.
- Awareness / understanding of company products, processes, procedures and personnel/structure.
- Strong analytical and communication skills are essential together with the ability to manage workloads to ensure high standards are maintained.
- Root cause investigation and problem-solving skills essential.
Inclusion and Belonging: Committed to welcoming, celebrating and thriving on inclusion and belonging.
Your Future: Generous annual bonus and pension schemes, Save As You Earn share options.
Work/Life Balance: Flexible vacation and time off, paid holidays and paid volunteering hours, so we can give back to our communities.
Your Wellbeing: Private health and dental plans, healthcare cash plans, income protection, life assurance and much more.
Flexibility: Hybrid working model (for most professional roles).
Training: Hands-on, team-customised, mentorship.
Extra Perks: Discounts on gyms and fitness clubs, salary sacrifice bicycle and car schemes and many other employee discounts.
Operational Quality Specialist employer: Smith & Nephew
As an Operational Quality Specialist, you will thrive in a dynamic environment that prioritises quality and compliance within the Medical Device and Pharmaceutical industry. Our company fosters a culture of inclusion and belonging, offering generous benefits such as flexible working arrangements, comprehensive health plans, and opportunities for professional growth through tailored mentorship. With a commitment to employee wellbeing and community engagement, we ensure that our team members feel valued and supported in their roles.
StudySmarter Expert Advice🤫
We think this is how you could land Operational Quality Specialist
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already working in quality roles. 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 ISO standards and quality management systems. We want you to show off your analytical skills and problem-solving abilities, so have some examples ready!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values. Check out our website for openings that match your skills and interests, and make sure to tailor your approach to each role.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind and show your enthusiasm for the role. Plus, it’s a great chance to reiterate why you’re the perfect fit for the team.
We think you need these skills to ace Operational Quality Specialist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experience that match the Operational Quality Specialist role. Highlight any relevant quality control experience, especially in the Medical Device or Pharmaceutical industry, to catch our eye!
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 makes you a perfect fit for our team. Don’t forget to mention your problem-solving skills and any experience with ISO standards.
Showcase Your Analytical Skills:Since strong analytical skills are essential for this role, be sure to include examples of how you've used these skills in past positions. Whether it's through root cause investigations or managing quality issues, we want to see your expertise in action!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Smith & Nephew
✨Know Your Quality Standards
Familiarise yourself with ISO 9001 and ISO 13485 standards, as well as any specific quality processes relevant to the company. Being able to discuss these standards confidently will show that you understand the importance of compliance in the role.
✨Showcase Your Analytical Skills
Prepare examples from your past experience where you've successfully conducted root cause investigations or problem-solving. Be ready to explain your thought process and how you arrived at your conclusions, as this will demonstrate your analytical capabilities.
✨Communicate Effectively
Practice articulating your thoughts clearly and concisely. Since strong communication skills are essential for this role, consider doing mock interviews with a friend or mentor to refine your delivery and ensure you can convey complex information simply.
✨Understand the Company Culture
Research the company's commitment to inclusion and belonging. Be prepared to discuss how you can contribute to this culture and why it matters to you. Showing that you align with their values can set you apart from other candidates.
