Quality Engineer III
Thermo Fisher ScientificSalary not specified
- Full Time
- Junior (1 to 2 years)
$60,000 – $80,000Compensation
Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, Medical Devices, Quality AssuranceIndustries
Requirements
Candidates should possess an Associate’s degree in a relevant field, or equivalent experience, and demonstrate a minimum of 3 years of experience in quality systems, preferably within a pharmaceutical or medical device environment. Strong organizational skills and attention to detail are essential, along with the ability to interpret and apply regulatory guidelines.
Responsibilities
The Associate Quality Specialist will be responsible for preparing and reviewing protocols for equipment, utility, process validation, cleaning validation, and facility qualification. They will coordinate with cross-functional teams, monitor the Quality Management System (QMS), conduct audits, and investigate non-conformances. Additionally, the role involves creating and maintaining validation calendars, updating protocols based on regulatory requirements, and compiling data for regulatory submissions, while also ensuring CFS closure and participating in daily validation activities.
Skills
Protocol Review
Equipment Validation
Utility Validation
Process Validation
Cleaning Validation
Facility Qualification
QMS
Audits
Non-Conformances
Regulatory Guidelines
CFS Closure
Data Compilation
Regulatory Submissions
Baxter International
Provides essential medical products and services
About Baxter International
Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.
Key Metrics
Deerfield, IllinoisHeadquarters
1931Year Founded
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees