Minimum 8-10 years related experience in a Quality Assurance of Medical Device manufacturing environment. Ensure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210/211, Part 820, ISO 13485 and Canadian Medical...
Responsible for execution and performance of Lantheus CQA quality system elements including GCP audit programs, regulatory inspection preparation support, continuous improvement, and quality system procedural documents. Bachelor's degree in a scientific discipline and 3 to 7 years' experience in the...
Minimum of 7-10 years quality assurance / supplier quality engineering experience in a pharmaceutical/life-science environment. Monitor supplier quality events utilizing the Lantheus Quality System, as appropriate. Summary of Role Plans, organizes, directs and reports on quality activities to assure...
Job Title: Quality Assurance Tech I. The QAE is responsible for conducting various tests on robotic systems to ensure product quality, performance and reliability. ...
Objectives involve ensuring patient and employee safety and the achievement of customer quality requirements, creating, monitoring, and improving quality systems/programs, reducing quality costs, and maintaining compliance within FDA and ISO regulations for +$500 million in annual sales. Director of...
Years Quality Assurance experience in a Food Production Manufacturing plant. The right candidate will be responsible for managing all resources relating to quality. This would include development, implementation, and all programs that would improve the quality of the product, safety, technology, and...
The Quality Assurance Manager will manage the Quality Assurance staff and support NEIDL Leadership with audits and other areas of QA expertise where required or determined to be beneficial to NEIDL operations. The Quality Assurance Manager will report to the Chief Safety Officer and will interact wi...
Our Initiatives include: Workplace Safety Roadway Security Impairment We are currently looking for a Program Delivery Quality Assurance Monitor to join us in our mission to save lives and prevent injuries. Position Highlights: Under general supervision, the Instructor Service Specialist is ass...
Quality Engineer who, under minimal supervision, provides Quality oversight activities for the aseptic fill/finish manufacturing suite and Quality Assurance technical expertise to ensure aseptic manufacturing facility, processes, and support systems are compliant with company guidelines and CGMP reg...
Strict compliance with quality, occupational safety, and environmental regulations. Implementation of the instructions of the quality / environmental management representative and the occupational safety specialist. ...
Analyze and review test packets, creating detailed test logs to track quality assurance. Oversee multiple projects concurrently, ensuring that quality standards are consistently achieved. Address quality issues promptly and develop effective solutions. Create or update procedures for capturing, inve...
We are seeking a dedicated Quality Specialist to join our team, reporting to the Senior Director of Quality Engineering. In this role, you will be pivotal in managing and supporting the development, maintenance, and resolution of Device Quality Management System (QMS) records. Your primary responsib...
Participate in the continuous improvement of QA processes and methodologies, contributing to the overall quality assurance strategy. ...
Quality Assurance of Medical Device manufacturing environment. Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210/211, Part 820, ISO 13485 and Canadian Medical Devices Regulations (CMDR SOR/98-282), EU Medical Device Regulation 2017/...
The Quality Assurance (QA) Compliance Specialist I performs compliance activities in support of production, engineering ensuring all activities are performed according to internal Quality System requirements, cGMP, FDA and ISO 13485 standards. Provide quality assurance support of investigations incl...
PRIMARY RESPONSIBILITIES Monitor production processing through quality and process audits Conduct necessary inspection using proper equipment and techniques Maintain calibration system Assist in Root Cause Corrective Action investigation Conduct statistical analysis and report findings Maintain accu...
Years Quality Assurance experience in a Food Production Manufacturing plant. The right candidate will be responsible for managing all resources relating to quality. This would include development, implementation and all programs that would improve the quality of the product, safety, technology and o...
Senior Associate, Quality Assurance (Billerica). Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system. Perform review of release, stability, validation, analytical quality control tests on raw materials, in-processing and final products. ...
GCP Clinical Quality Assurance (CQA) oversight: Responsible for execution and performance of Lantheus CQA quality system elements including GCP audit programs, continuous improvement, and quality system procedural documents. Bachelor’s degree in a scientific discipline with 10+ years’ experience in ...
A Testing and Quality Assurance is needed for an American defense, aviation, information technology, and biomedical research company in the Tewksbury, MA area. This role manages technical quality assurance, oversees manufacturing QA/QC practices, conducts inspections, and coordinates supplier audits...
Responsible for execution and performance of Lantheus CQA quality system elements including GCP audit programs, regulatory inspection preparation support, continuous improvement, and quality system procedural documents. Bachelor’s degree in a scientific discipline and 3 to 7 years’ experience in the...
Responsible for providing Quality Assurance planning and leadership by identifying critical quality elements and bringing together the groups required to establish preventative measures to ensure product quality. A successful quality assurance manager will be well organized, able to multitask in a f...
We are looking for a Quality Assurance Manager. Develop the BU Quality strategies and objectives in alignment with JESA Overall Quality objectives. Develop and execute comprehensive and specific Quality Assurance plans to O&M scope of services. Ensure that JESA Quality expectations and Customer Qual...
We are seeking a talented and highly motivated Quality Assurance Engineer (QAE) for a contract position. QAEs regularly work with Developers, Product Managers, and other Quality Engineers to ensure the proper operation of the production environment. The QAE is responsible for conducting various test...
Minimum 8-10 years related experience in a Quality Assurance of Medical Device manufacturing environment. Ensure compliance of establish Quality Management System (QMS) and in compliance with corporate requirements and all applicable FDA Part 4, Part 210/211, Part 820, ISO 13485 and Canadian Medical...