Quality Engineer
Owens & Minor60,000 - 90,000 USD/year
- Full Time
- Junior (1 to 2 years), Mid-level (3 to 4 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Healthcare, Life SciencesIndustries
Requirements
Candidates must possess a Bachelor’s degree in Biomedical Engineering, Industrial Engineering, Chemistry, or a related field, and a minimum of three years of experience as a Quality Engineer or equivalent role within the medical device or pharmaceutical industry. Direct experience with ISO 13485:2016 and 21 CFR 820 is required, and ASQ certification is desired.
Responsibilities
The Quality Engineer III will facilitate risk management activities in compliance with ISO 14971:2019, maintain risk management files, approve process and product validations (IQ/OQ/PQ), ensure compliance to the Quality Management System, collaborate with teams to develop solutions, review and approve CAPA action plans, complete CAPA effectiveness checks, collaborate in the resolution of non-conformances, make product disposition decisions, and participate in quality improvement initiatives. They will also represent the quality function in customer-facing meetings and support internal and external audits.
Skills
ISO 14971:2019
Risk Management
Process Validation (IQ/OQ/PQ)
CAPA
Quality Management System
Product Disposition
Non-conformance Resolution
Customer Communication
Quality Improvement
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Key Metrics
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees