Job Summary:
We are seeking a skilled Senior Quality Assurance Specialist to join our team in a dynamic and innovative organization. This is an exciting opportunity for a motivated individual to take on a challenging role in ensuring the highest quality standards in product testing and lot release.
Key Responsibilities:
1. In-process and final product review of documents for accurate format, signatures, dating, and Good Documentation Practices (GDP) for commercial products in a timely manner.
2. Perform in-process product inspection and testing for commercial products as conforming to specified requirements in accordance with product specifications and quality assurance standards.
3. Prepare, record, and update inspection report forms.
4. Conduct transactions related to Lot Release in a defined system.
5. Work closely with Quality Engineers, Manufacturing, Process Engineers, and other functions on any issues that arise in relation to the Lot Release process.
6. Maintain compliance with operating procedures and ensure training is completed prior to the operation of a task.
7. Monitor equipment and instrumentation to ensure there are no issues and equipment is clean and safe to use.
8. Ensure all documentation and labeling is legible, complete, and correct per current Good Manufacturing Practices.
9. Assist in setting up the Lot Release Department and associated Lot Release Lab.
10. Conduct TMVs and troubleshoot test methods.
11. Initiate and assist with the NCMR process during manufacturing of commercial products.
Requirements:
* A minimum Level 6 qualification in Quality, Engineering, or a related discipline.
* 4-6 years' experience within the medical device industry.
* Demonstrate strong interpersonal and teamwork skills and written and verbal communication skills.
* Flexibility to work in different shifts to meet demand.
* Proficiency with statistical analysis (e.g., Minitab) and Microsoft Office Products (Word, Excel, Outlook) is desirable.
What We Offer:
* A front-row seat to life-changing CGM technology.
* Learn about our community.
* A full and comprehensive benefits program.
* Growth opportunities on a global scale.
* Access to career development through in-house learning programs and/or qualified tuition reimbursement.
* An exciting and innovative organization committed to its employees, customers, and communities.