Danaher Corporation Quality Compliance Officer (Product & Technology) 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 creates 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.
The Quality Compliance Officer is an exciting new position at PNI, a global leader in its area. The Compliance Officer will be at the forefront of PNI’s entry into new markets and product areas. The Quality Compliance Officer leads and plans compliance, and is responsible for managing product type approvals and maintaining regulatory evidence. This individual should be knowledgeable in global compliance while establishing, maintaining and implementing process changes. The Quality Compliance Officer will be accountable for preparing compliance procedures to implement applicable new regulations/legislative changes. He/She would be the in-house subject matter expert on compliance and support PNI, both managing internal and external stakeholders. In addition, he/she would ensure compliance with all applicable standards for product and technology matters across the business unit. The Quality Compliance Officer reports directly to the Director of Product Quality and must work collaboratively across the business to add value and continuously improve the process.
What you'll do
Must possess a clear understanding of existing and projected global regulation, including product safety, electrical and electronic standard and regulations, product environmental compliance and restricted substances.
Working with product development teams to obtain certification for parts and products within the required time frame.
Serve as a subject matter expert on regulatory matters to ensure key and regulatory requirements are understood by product development teams and other key stakeholders.
Developing and implementing communication strategies including training programs to share product compliance information with the product development team, supply chain management and other support groups as well as customers and suppliers.
Interfacing with outside agencies so that the products can be formally tested and certified to meet designated requirements if required.
Coordinating the business unit implementation of the corporate restricted substances initiative which includes compliance with global regulations such as: EU ROHS, REACH, US EPA Conflict Minerals, ATEX Certification and all Environmental Health and Safety product compliance.
Providing gap analysis on compliance issues for existing and new products.
Developing sustainable processes for managing compliance activities with supporting documentation.
Reviewing all new part requests, engineering change control and deviations, to ensure requirements are met and maintained.
Staying informed of all upcoming changes to Product Safety and Compliance regulations and standards to ensure that the organization is meeting all current requirements for new and existing products.
Assessing how product regulations and standards impact new market entries (e.g. expansion into new countries, applications, etc.)
Leading risk assessment and facilitating hazardous operations/risk analysis of all potentially impacted products and reducing risk by ensuring changes to the business unit are relevant to product standards. In addition, that regulation changes are identified in a timely manner and appropriate action is taken.
Creating, compiling, and distributing compliance reports, quality measures, and risk management files.
Preparing reports for management review and/or compliance analysis for any new standards or changes to existing standards and how they may impact existing and new product and technology.
Conducting compliance implementation audits and immediately reporting compliance issues and concerns to the Director of Product Quality.
Facilitating any compliance and regulatory customer questionnaires and review standard response positions to customer inquiries.
Hosting regulatory and customer audits where required.
Performing other duties and special projects as assigned.
Who you are
Can demonstrate in depth knowledge of applicable product and technology compliance such CE marking, Low Voltage Directive, EMC Compatibility, EU ROHS, REACH, US EPA Conflict Minerals, ATEX Certification and all Environmental Health and Safety product compliance.
Uses knowledge to advise on continuous improvement.
Strong knowledge of operational and business processes.
Excellent coordination and administration 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.
Integrity and resilience under pressure
Strong planning and organizational skills
Proficient in using Microsoft Office applications.
Degree in life-science, engineering or business-related field is required or equivalent experience in Quality in a similar ISO regulated /GMP business industry.
Minimum of 3 years of quality assurance experience with customer and auditor interaction.
Certified auditor (internal auditor and/or Lead Auditor)
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.