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Senior Quality Assurance Specialist
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Job Summary
We are seeking a Senior Quality Assurance Specialist to join our team at Thermo Fisher Scientific. As a key member of our quality assurance department, you will be responsible for ensuring the highest level of quality in our products and services.
About the Role
The Senior Quality Assurance Specialist will be responsible for:
- Conducting visual inspections, measurements, and functional testing of pipette tips, tubes, and racks using various equipment.
- Evaluating results and verifying specifications and tolerances as specified on product drawings or Product Quality Requirements.
- Using Agile PLM to read drawings, interpreting drawing requirements, and tolerances.
- Communicating results to the immediate supervisor of any deviation to established standards.
- Collaborating with product design and metrology engineers to develop equipment and fixturing for new product development projects.
- Maintaining lab equipment, establishing traceability of laboratory standards.
- Writing lab procedures and associated training materials using Agile System.
- Collaborating on creating or refining measurement routines for CMM and VMM equipment.
- Executing protocols and test plans in the evaluation of plastic components supporting quality engineers.
- Managing the release of manufacturing lots.
Requirements and Qualifications
To be successful in this role, you will need:
- A technical career or equivalent.
- 5 years' experience related to quality control, preferably in a quality laboratory department with medical devices ISO 13435 and FDA 21 CFR part 820 environment.
- Specific experience with various measurement equipment such as CMM, vision measurement systems, and mechanical gauging/fixturing.
Preferred Skills and Qualifications
Prior experience in a similar role is preferred, but not required. We welcome applicants who have:
- Ability to interpret drawing requirements and tolerances.
- Knowledge of working in a lab environment.
- Ability to manage, lead, and motivate a QA team.
- Ability to write reports/protocols.
- Ability to function in a multifaceted environment and balance multiple priorities simultaneously.
- Strong computer skills, including Microsoft Office, with a focus on MS Excel, and software systems (Agile, Trackwise, Macola).
- Intermediate math skills.
Compensation and Benefits
The salary range for this position is between $85,000 - $110,000 per year, depending on experience and qualifications.
