10 reasons to hire a QMS consultant instead of a permanent employee
A Quality Management System is a process that a company must implement to ensure that their products meet certain safety and quality standards in order to release them to the market. For medical devices, the benchmark regulation is ISO 13485 and this serves as a comprehensive guide for the design and manufacture of medical devices. In order to sell products in regional markets such as the European Union, a QMS will require flexible and talented professionals in order to comply with different regulations and to be able to acquire and maintain a CE Mark.
The type of QMS required depends on what sort of product is being manufactured and what the regulation associated with it is. It will also vary depending on the risk-level associated with the product being manufactured, with high-risk products requiring a more complex QMS. Some products such as Software as a medical device require extremely specialist knowledge to interpret and comply with regulations regarding patient safety and confidentiality. A QMS consultant will have experience and expertise, and the flexibility to be brought in quickly to plug a gap in your company’s knowledge and to quickly implement a Quality Management System.
Why should you hire a QMS consultant? There are many reasons why it makes sense for a company to hire a consultant over a permanent hire or using a consultancy, here are 10 reasons why you should consider it…
1. Implement QMS quickly and efficiently
QMS consultants will have great expertise in implementing various Quality Management Systems. They will be used to quickly settling into new projects and will be able to hit the ground running at your company. If you want to be able to quickly implement a new QMS, a contractor will have the right experience to help you do just so.
2. Maintain a flexible QMS
QMS contractors will have the technical knowledge needed to join a company and ensure it can maintain and build a flexible QMS that works for your business and is not too heavy to be a burden. You can fluidly maintain your QMS, and a contractor can help you develop it with their outside knowledge and perspective.
3. QMS freelancers provide QMS training
Experienced QMS freelancers with management experience will be able to recognise gaps and opportunities for improvement in your team’s QMS approach and arrange training for employees that can have a lasting positive impact on your company.
4. Comply with new QMS regulations
QMS consultants can help your company comply with both existing and new regulations. If there is a particular new regulation that your company is less familiar with, a contract hire can help you tackle it without any delay. A good QMS consultant can also implement state of the art processes and approaches to help your QMS be as fluid and up to date as possible.
5. QMS consultants can help you navigate the compliance process without delays
Some QMS consultants will have previously worked for third party auditors or notified bodies, so they will know what exactly the notified body auditors look for thus ensuring that your product is in the best position to comply with regulations.
6. Specific QMS expertise
A great benefit of hiring a QMS consultant is that you will be able to bring in the exact knowledge that you are looking for. Want to manufacture a new product and your existing team is less familiar with the QMS? A contract hire can allow you to navigate that process confidently and without potentially having costly mistakes or delays.
7. Smooth handover to your internal team
QMS contractors are extremely experienced and in a position where they can perform an advisory role and offer training for your staff. This will allow them to pass on knowledge and ensure a smooth handover to your internal team.
8. QMS consultants are a cost-effective solution
QMS consultants are paid by the hour which allows you flexibility in planning out costs, they can also be brought in quickly which avoids the sometimes drawn-out process of making a permanent hire and allows you to ensure that you stay within your budget. Also, you only use them for as long as you need. A QMS consultant hire allows you to scale up and down effectively without the HR and legal constraints of a perm hire.
9. Bring the right person in immediately
QMS contractors can be hired in a matter of weeks, rather than in the 3-6 months that making a permanent hire can take. This allows you to be extremely flexible and reactive towards implementing and maintaining your quality management system.
10. Total package (high expertise, cost-efficient, quick solution)
The key benefit of hiring a Quality Management System Consultant is that you can find exactly the right person with the skill set and specific knowledge that your company requires, and bring that person in quickly! To help you find that person, at Elemed we have expertise in finding experienced QMS consultants and can tap into our extensive network of contacts that are constantly poised to listen to new opportunities. If you want to make a hire that will give you maximum flexibility and allow you to implement and maintain your QMS smoothly and comply with any new or old regulations, get in touch with us today to discuss your specific needs.