About Precision NanoSystems Inc. (PNI)
Precision NanoSystems Inc. (“PNI”) is a manufacturer of instruments, kits and reagents in the global nanomedicine market providing tools for drug development and cell-specific delivery to study, diagnose and treat disease. PNI’s NanoAssemblr family of instruments allow scientists to rapidly develop novel nanomedicine drug candidates for pre-clinical testing. PNI’s NanoAssemblr Scale-up platform enables the translation of these drug candidates to clinical testing and eventually to commercial use. PNI’s NanoAssemblr™ Transfection Reagents use nanomedicine technology to deliver genetic materials in primary cells vitro and in vivo, enabling disease researchers to easily study gene function in high-value models of disease. PNI sells its products to leading pharmaceutical and biotechnology companies, and leading academic institutions in over 20 countries worldwide. Please find more information at http://www.precisionnanosystems.com/ .
Position Summary
The Quality Analyst ensure that the quality standards of the company are maintained within PNI procedures, policies, purchased components, manufactured products and customer satisfaction. The Quality Analyst will support the implementation of processes and procedures including the Quality Management System as well as support other functions of the Quality Department as needed. This position is responsible for assisting in monitoring the processes and procedures of the Quality Management System. Initiating problem solving, root cause analysis, remediation, correction and prevention as appropriate. This includes completion of all supporting.
Job Responsibilities
Actively participate in corrective and preventative action processes by providing technical expertise in root cause analysis and action plan development to prevent and eliminate issues
Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
Support new product launches, ensuring compliance with established standards
Drive and initiate continuous improvement using feedback from customer issues to improve customer satisfaction
Support PNI’s supplier quality management process to establish quality requirements from external suppliers
Perform quality systems and compliance audits, including supplier audit as required
Support in maintaining and developing PNI’s Quality Management System (QMS) required for the manufacture and distribution of products
Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes
Effectively interact the across organization to maintain product quality and customer satisfaction
Qualifications and Experience
Degree in life-science, engineering or business-related field is required
3-5 years of quality assurance experience in a biotech industry, medical device or in a relevant industry
Experience in implementing quality systems (such as ISO 9001, ISO 13485 or similar)
Ability to assess assigned tasks to identify potential challenges and communicate effectively
Ability to manage and lead projects in a cross functional environment
Proficient in application of QA principles, concepts, industry practices, and standards
Thorough understanding of the ISO 9001 standard and other international quality systems regulations to adopt best in class systems and processes
Solid experience in implementing Statistical Process Control
Analytical, detail oriented and excellent grasp of problem-solving skills
Ability to influence individuals and teams to achieve desired goals and objectives and supporting contributors and across organizational levels
Excellent verbal communication, technical writing and interpersonal skills
Ability to effectively manage multiple projects/priorities
Strong planning and organizational skills
Proficient in using Microsoft Office applications
Experience in using Sharepoint is an asset
Experience in Lean Six Sigma is an asset
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
If you’ve ever wondered what’s within you, there’s no better time to find out.