- Tests systems and implements validation packets.
- Validates and qualifies equipment for use in manufacturing and quality control testing of products.
- Assists in drafting validation protocols and reports, as well as developing written maintenance procedures.
- Identifies and documents potential gaps based on validation tasks performed.
- Conducts validation exercises for technology and manufacturing systems to support in-line products and processes at manufacturing sites.
- Performs validation of process equipment installation, operational, and performance qualification studies to assess functionality.
- Executes operational qualification assessments to ensure critical operating parameters are within qualified parameters.
- Implements equipment enhancements as directed to support intended qualified operational ranges.
- Documents deviations and/or investigations related to remediation activities.
- Experience in performing quality validations within a manufacturing environment within medical device
- Proficient in validation testing and development of statistical process control and monitoring.
- Understanding of medical device regulations and standards
- Ability to write technical reports and correspondence.
- Ability to use statistics and mathematics.
- Ability to solve practical problems and deal with a variety of concrete and abstract variables in situations where only limited standardization exists.
- Intermediate skill in the use of Excel, Word and PowerPoint. Advanced preferred.
- Will often work near moving mechanical parts.
- Travel may be required.
- There will be extended periods of sitting and using a computer.
- The noise level in some of the work environments can be unusually loud and require hearing protection.
- Potential exposure to caustic chemicals.
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Quality Validation Specialist - Eastleigh, United Kingdom - CooperCompanies
Description
JOB TITLE : Quality Validation Specialist (2 year Fixed Term Contract)
LOCATION : Hamble or Chandlers Ford, Eastleigh
WORKING HOURS : Monday to Friday 37.5 hours per week
A brighter future awaits you
At CooperVision, we are proud to be the global leader in contact lenses. At our innovative sites worldwide, we manufacture and distribute contact lenses to some of the biggest names in optics. We're all about creating brighter futures for our customers, our wearers and our people.
What can you expect from us as an employer?
Well, we like to look at things a little differently. We call it bringing a refreshing perspective. And for every one of us who works here, it means our opinion really counts, we get to share our ideas, and we get to make an impact.
We're big on belonging. Because being part of something great is what makes our company the best it can be. And we value diversity, because you can see a whole lot more when you have different perspectives. We're an ambitious company. And to help us achieve our goals, we'll give you all you need to achieve yours.
What will you be doing?
We have an exciting opportunity for a Validation Specialist to join our Quality Assurance team on a 2 year fixed term contract. As Validation Specialist, you willprovide assistance to the Senior Quality Improver and/or Validation Engineers in carrying out a range of validation and testing tasks necessary to meet domestic and international quality standards within the Global Quality Engineering function. This role will focus particularly on supporting MDR remediation activities at the manufacturing site, including validations, procedural changes, and training support,
Essential responsibilities:
What are we looking for?
This would be an ideal opportunity for someone starting out in their career with some experience. We would like you to have the following:
Work Environment
What do we offer?
You'll receive competitive compensation and a fantastic benefits package including; 25 days holiday, pension scheme, healthcare cover, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more
What is important to us?
Our four values define and underpin our unique culture; we are dedicated, we are inventive, we are friendly, and we are partners. Becoming part of the CooperVision family means joining a friendly team that's open, flexible, and respectful of each other's differences, working together to achieve something amazing.
Recruiting, retaining, and promoting a diverse mix of employees is core to our success. It helps bring different perspectives, diverse conversations, and new ideas to the table, all of which are incredibly valuable.
At CooperVision we celebrate, not only our company success, but we celebrate who we all are individually, and we embrace diversity. We support and we encourage you to bring your full self and not just part of you. We are committed to each individual and we look forward to a Brighter Future together.
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