- Manage audit processes and procedures for multiple teams of software engineers and scientists in a SaaS hosted application development cycles.
- Work with Product Management and software product owners to ensure new features and improvements for multiple products remain compliant and adherent to ISO standards / IVDR.
- Consult closely with senior leadership within the QIAGEN Digital Insights organization to evaluate and prioritize resources and align with the long-term vision of the organization for compliance.
- Deep understanding and direct experience-practical and managerial-in one or more of the following:
- ISO standards for ISO9001, ISO13485 / IVDR, HIPAA, etc.
- Understanding of the development of bioinformatics software / pipelines to satisfy needs of multiple users or customers.
- Direct experience working in a Quality Management System (QMS) under ISO 9001, ISO 13485, and/or IVDR (Master Control, Polarion, or similar)
- Deep understanding of the biomedical domains and development of software/automated solutions
- Prior experience in process management for ISO compliance and software development lifecycle management across multiple development teams and products.
- Demonstrated competency and experience supporting Regulatory, Medical, and Clinical Affairs teams to ensure compliance for our Life Science and MDx products and tools around human disease and genetics.
- Experience with Agile software development practices and working in a scrum framework.
- Familiarity with software development tools such as JIRA and Confluence.
- Exceptional communication and interpersonal skills: ability to interact and work well with members of other functional teams within and outside the organization.
- 10+ yrs experience in software development (SaaS), life-sciences, bioinformatics, or a related area.
- Willingness to embrace challenges and collaboratively problem-solve issues as a self starter.
- Ability to listen and align / implement efficient policies, processes and best practices.
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Sr Specialist QA Compliance - Redwood City, United States - Qiagen N.V
Description
OverviewAt the heart of QIAGEN's business is a vision to make improvements in life possible.
We are on an exciting mission to make a real difference in science and healthcare.
We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees - more than 6000 in over 35 locations around the world.Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.
Position Description
QIAGEN Digital Insights is a leading provider of bioinformatics software and knowledge bases used by life scientists to gain insight from the molecular information in their biological samples.
We are passionate about our users, products, and our vision, and are seeking smart, motivated engineers and scientists who are eager to join our team in creating software that helps improve people's lives.
This is an excellent opportunity for a person that has strong experience in audit best practices and previous experience in designing and adhering to processes for R&D compliance.
This role is for a full-time position within the QIAGEN Digital Insights organization and specifically within the scientific/bioinformatics Operations Team.
ResponsibilitiesAt the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.
QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person's appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.
QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs.
Candidates who require accommodation should contact This policy is part of QIAGEN's ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community.
