Quality Engineer III
Thermo Fisher ScientificSalary not specified
- Full Time
- Junior (1 to 2 years)
$60,000 – $90,000Compensation
Senior (5 to 8 years), Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Quality AssuranceIndustries
Requirements
Candidates should possess a Bachelor’s degree in Engineering, preferably Biomedical, Mechanical, or Chemical Engineering, and have a minimum of 8 years of experience in quality engineering, specifically within the medical device industry. Strong knowledge of Design Controls, CAPA, and regulatory requirements (FDA, ISO 13485) is essential, along with experience in Design Verification and Validation activities.
Responsibilities
The Sr. Quality Engineer will lead on-time completion of Design Control deliverables, create and ensure on-time execution of Quality Plans for various projects, and be accountable for Design Verification and Validation planning and execution, including root-cause analysis and resolution. They will also lead Risk Management activities, support manufacturing process development and qualification, and ensure DHF content completion and regulatory compliance, while supporting audits and re-certifications.
Skills
Design Controls
CAPA
FDA
ISO 13485
Design Verification
Design Validation
Risk Management
Root Cause Analysis
Regulatory Compliance
DHF
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