Quality Assurance Specialist
OkloSalary 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
Pharmaceutical, Medical DevicesIndustries
Requirements
Candidates should possess experience in Quality Assurance, along with a strong understanding of applicable internal and external requirements such as FDA QSR and ISO 9001/ISO 13485. They must be able to interpret regulations, guidance, and standards, and demonstrate strong communication and collaboration skills, complemented by experience with document development and change control.
Responsibilities
The Senior Specialist Quality Assurance will identify internal requirements and external laws, regulations, guidance, and standards, interpret them, and incorporate them into requirements for use in business processes internally or with external partners. They will also identify areas of potential noncompliance, assist in the development and change control of Quality System and partnership related documents, participate in cross-functional activities to standardize Abbott’s business quality system policies and procedures, and ensure internal and external activities meet applicable regulations and quality standards, while contributing to the creation and maintenance of documentation aligned with Quality System requirements.
Skills
FDA QSR
ISO 9001
ISO 13485
Quality Assurance
Regulatory Compliance
Document Development
Change Control
Communication Skills
Collaboration
Requirements Interpretation
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