Quality Engineer III
Thermo Fisher ScientificSalary not specified
- Full Time
- Junior (1 to 2 years)
$60,000 – $90,000Compensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Pharmaceutical, Quality AssuranceIndustries
Requirements
Candidates should possess a Bachelor’s degree in a relevant scientific or technical field, and have a minimum of 7 years of experience in Quality Assurance, with a strong preference for experience within the medical device or pharmaceutical industries. Demonstrated knowledge of FDA regulations (QSR), ISO 13485, and other relevant quality standards is essential, along with experience in auditing and risk management.
Responsibilities
The Senior Specialist Quality Assurance will be responsible for interpreting internal and external requirements, translating them into documents such as procedures and partnership agreements, and ensuring alignment with the Quality System. This role involves identifying areas of potential noncompliance, assisting in the development and review of quality system documents, participating in cross-functional activities to standardize Abbott’s business quality system, and ensuring that internal and external partnership activities meet applicable regulations and quality standards, including FDA QSR and ISO 9001/ISO 13485.
Skills
FDA Regulations
QSR
ISO 13485
Auditing
Risk Management
Quality System
Internal Requirements
External Requirements
Quality System Documents
Cross-functional Activities
Regulatory Compliance
Abbott
Healthcare solutions in diagnostics and devices
About Abbott
Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.
Key Metrics
Lake Bluff, IllinoisHeadquarters
1888Year Founded
IPOCompany Stage
HealthcareIndustries
10,001+Employees