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Senior Quality Engineer
VERO BiotechUnited Statesfull_timeVerifiedPosted 12 Feb 2025
About the role
Job Details
Job Location Atlanta, GATravel Percentage NoneDescription
- Act as primary quality resource for designated product area and/or quality subsystem to ensure compliance with ISO 13485, cGMP, FDA (ie. 21 CFR part 11, 21 CFR part 210/211, 21 CFR part 820) and other relevant regulations and industry standards
- Work closely with other teams (such as engineering, manufacturing and regulatory affairs) to facilitate the application of design/change controls to support the design and development of products, from design planning to design transfer as well as human factors and life-cycle management
- Support and/or maintain risk management files, ensuring risk assessments and failure mode and effects analysis (FMEA) identify and mitigate potential issues
- Understand and integrate customer requirements into manufacturing and quality system requirements
- Oversee design, manufacturing process and equipment verification and validation activities
- Assists in development of project plans, protocols, and reports, including thorough investigation and resolution of test failures per procedure
- Understand critical to quality design characteristics/specifications and apply to product and software development processes
- Participate in new and on-going supplier assessments and facilitates completion of qualification activities
- Act as technical specialist to Purchasing in supplier related quality issues
- Collaborate with cross-functional teams to address quality-related issues
- Support thorough root cause failure analysis and implementation of corrective and preventive actions to preclude recurrence and drive continuous improvement
- Analyze quality data, process capabilities, and customer concerns and expectations and any other leading or lagging indicators which may be used to improve product and process knowledge
- Develop and implement quality control procedures to ensure product quality and consistency
- Assume responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in process SPC programs
- Support regulatory inspections by FDA and ISO and/or corporate and supplier quality system audits as needed
- Performs other duties and responsibilities, as required
Qualifications
- BS in Engineering or related field and a minimum of 4 years’ experience in a regulated industry for Quality Engineer or 7 years’ experience for Sr. Quality Engineer
- Practical experience with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Documentation Practices, ISO 14971, and other applicable standards
- Ability to apply regulations to the development and manufacturing of medical devices and/or pharmaceuticals
- Direct experience in software quality assurance
- Working knowledge of engineering principles, concepts and practices for design and development activities, Risk Management, FDA and ISO regulations
- Expertise in statistical process control, design of experiments, and other quality management tools
- Experience in validating and qualifying manufacturing processes and equipment
- Certified Quality Engineer certification from American Society for Quality preferred
- Advanced proficiency in Microsoft Office products
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