Quality Assurance Specialist
4 weeks ago
Job Description:
We are seeking a highly skilled Quality Assurance Specialist to support our Operations Quality team during the New Product Launch of Capital Equipment.
As a Quality Assurance Specialist, you will be responsible for reviewing and approving validations (process, software, equipment) and working closely with Manufacturing Engineering to develop Operator Work Instructions and set up assembly stations.
You will also work directly with Inspection to establish inspection methods for new incoming components and assist in resolving inspection issues.
In addition to the primary task, your responsibilities may include:
- Developing, modifying, and maintaining quality standards and protocols for processing materials into partially finished or finished products.
- Collaborating with engineering and manufacturing functions to ensure quality standards are in place.
- Devising and implementing methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
- Designing or specifying inspection and testing mechanisms and equipment; conducting quality assurance tests; and performing statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensuring that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Requirements:
Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.
Key Skills:
Software, Process, and Equipment Validation experience; Experience working in Medical Device or other government-regulated industries; Ability to multi-task and handle both project work and day-to-day activities.
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