Danaher Corporation Quality Engineer in Vancouver, British Columbia
Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie along the spectrum of Life Sciences to Industrial, you’ll find a rewarding role here. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.
Pall is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
About Precision NanoSystems Inc. (PNI)
Precision NanoSystems Inc., part of Pall Corporation, is a biotechnology company that builds innovative solutions for the discovery, development and manufacture of novel nanoparticles for use as medicines and in medical research. PNI’s proprietary NanoAssemblr® microfluidics platform and GenVoy® lipid nanoparticle delivery platform enable the rapid, reproducible, and scalable manufacture of next generation nanoparticle formulations for the targeted delivery of therapeutic and diagnostic agents to cells and tissues in the body. Our overall goal is to accelerate the creation of transformative medicines that significantly impact human well-being.
Reporting to the Director of Product Quality, the Quality Engineer will be an integral part of of the Quality Assurance team. The aim of a Quality Engineer is to make sure that final products are safe, reliable, consistent, and meet customer expectations, while keeping the manufacturing process as lean and cost-effective as possible. If you have experience with ISO 9001 and the development of quality systems, this may be the position of a lifetime.
What you'll do
Supervising the quality assurance function to assure quality production is in accordance with customer specifications.
Conducting audits of production processes to assure that all prescribed quality procedures are adhered to without compromise.
Performing quality investigation, keeping oversight of quality complaints (internal and external) and managing the metrics and KPI’s related to quality issues.
Handling external customer complaints and the related day-to-day communication with other departments.
Identifying shortfalls, developing corrective measures, and implementing quality control systems to meet established quality standards.
Ensuring all products, processes, methods and equipment are validated. Maintaining the overview of the validated state and handling any deviations.
Acting as quality representative in Quality improvement projects and / or sustaining projects. Recommending solutions that will improve product durability and overall performance.
Creating documentation, devising quality tests and defines the criteria a test result should meet. Setting out appropriate tests and acceptable result parameters to ensure that quality testing throughout the manufacturing process is effective.
Translating customer requirements into quality control and the process FMEAs.
Closely engaging in product development projects towards the introduction of new products as quality lead.
Determining quality improvement parameters by identifying statistical methods relevant to manufacturing processes
Supporting new product launches, ensuring compliance with established standards
Supporting, maintaining and developing PNI’s Quality Management System (QMS) required for the manufacture and distribution of products.
Driving and initiating continuous improvement using feedback from customer issues to improve customer satisfaction
Performing quality systems and compliance audits, including supplier audits as required
Supporting PNI’s supplier quality management process to establish quality requirements from external suppliers.
Leading and monitoring PPM improvement efforts for new and existing parts.
Performing other duties and special projects as assigned.
Who you are
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.
Excellent problem-solving abilities.
Solid experience in implementing Statistical Process Control
Knowledge of applicable validation processes and methodology.
Analytical, detail-oriented, with an 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 working in a regulated GMP environment is an asset.
Experience in Green Belt/Black Belt Certification is an asset.
Certified Quality Engineer (CQE) certification is an asset.
Certified Lead Auditor is an asset.
Bachelor Degree in life-science, engineering or equivalent experience in Quality in a similar business industry is required.
Minimum of 5 years of quality assurance experience in a biotech industry, medical device or in a relevant industry with at least 1 year of experience in a quality advisory role.
Experience in implementing quality systems (such as ISO 9001, ISO 13485 or similar)
Understanding of statistical improvement tools and lean manufacturing techniques.
Ability to manage and lead projects in a cross functional environment.
Ability to assess assigned tasks to identify potential challenges and communicate effectively
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 (https://www.danaher.com/how-we-work/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.