1240 IT & Software Developer jobs in the US
Senior Software Validation Engineer
$101,000 - 152,000
Medline Industries - Transportation & Operations
Willow Road 888, Winnetka
$101,000 - 152,000
Requirements
Must:
- Bachelors degree in Engineering, Quality, Business, or Computer Science.
- Minimum of 5 years of experience in Manufacturing, Quality or Engineering.
- At least 3 years of experience in GAMP 5 related computerized system validations, including designing, authoring, executing, and coordinating.
- Direct experience in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principles of Software Validation, and Electronic Records/Signatures.
- Knowledge of standard concepts, practices, and procedures within software engineering.
- Demonstrated experience in influencing, leading, and directing individuals across multiple functional areas.
- Proven track record in project management, including planning, organizing, and managing resources to achieve project objectives.
- Familiarity with working in an AS400 environment.
Responsibilities
- Assess systems and applications to design organized and efficient validations related to software, processes, automation, cleaning, facilities, and utilities.
- Ensure that the scope and complexity of validations align with associated risks by developing and executing test strategies, plans, scripts, and procedures to fulfill requirements.
- Oversee multiple validation projects concurrently, understanding customer needs and providing regular updates on project progress to ensure client satisfaction.
- Prepare validation protocols and reports using clear and professional technical writing skills.
- Adhere to Medline policies and relevant governing procedures consistently.
- Stay informed about industry and regulatory changes, including FDA, GAMP, and ISO standards.
- Uphold organizational excellence in document control and quality record maintenance, emphasizing detail and thoroughness.
- Identify and implement improvements to enhance software validation processes and overall efficiency.
- Offer support to the team on all validation efforts and assist division facilities on-site when necessary.
Description
At Medline Industries, LP, we offer a leadership position focused on the development and execution of validation projects that ensure customer satisfaction and regulatory compliance. We provide a competitive rewards package, continuous education, and growth opportunities within our expanding global organization. Our benefits include health insurance, life and disability coverage, 401(k) contributions, and paid time off for employees working 30 hours or more weekly. Were committed to fostering a diverse and inclusive environment where everyone can thrive in their career. Medline Industries is an equal opportunity employer.
Something wrong or incorrect with this job? Tell us in the chat 💬 on the right ➡️
You can find QA, Test Engineer salaries in the United States here.
How many QA, Test Engineer jobs are in the United States?
Currently, there are 1240 QA, Test openings. Check also: Selenium jobs, Cypress jobs, Cucumber jobs - all with salary brackets.
Is the US a good place for QA, Test Engineers?
The US is one of the best countries to work as a QA, Test Engineer. It has a vibrant startup community, growing tech hubs and, most important: lots of interesting jobs for people who work in tech.
Which companies are hiring for QA, Test Engineer jobs in the United States?
Jump, Sched LLC, DataAnnotation, AMS Networks LLC, Hi-Temp Insulation, NewCold, MTech Systems among others, are currently hiring for QA, Test roles in the United States.
The company with most openings is Jobot as they are hiring for 50 different QA, Test Engineer jobs in the United States. They are probably quite committed to find good QA, Test Engineers.
The company with most openings is Jobot as they are hiring for 50 different QA, Test Engineer jobs in the United States. They are probably quite committed to find good QA, Test Engineers.