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Qualio is a tech startup that is the first cloud quality management software for the entire Life Sciences ecosystem. Medical device and pharmaceutical companies need a secure and scalable quality management system with the flexibility to support their evolving needs. Qualio meets that challenge by cutting through the complexity to optimize and automate critical quality processes.
The Qualio team is all-remote, and currently distributed across North America and Europe.
As a Senior Quality Operations Specialist you will be working in the Quality Operations group in managing Qualio’s quality system compliance and validation activities.
To be successful in this role, you will be a solid communicator who is able to earn the trust of your teammates, as well as being comfortable communicating outside the team as needed, with all levels of an organization. You should be willing to learn about the industry we serve and be very comfortable in a fully remote, electronic environment.
- Manage and administer an ISO 9001/27001 quality system for our internal compliance
- Manage and administer the review, release and coordination of Qualio’s validation package for customers, including feedback on the validation documentation.
- Manage and coordinate Audits - including Customer and Internal Audits in coordination with other stakeholders.
- Perform periodic assessments of compliance activities utilizing established checklists and resources provided.
- Perform periodic assessments, support training compliance, management review meetings, Quality Event management, etc.
- Other duties as required
- 5+ years experience in computer software validation
- Strong technical skills and understanding of software systems, and an ability organize information under direction of staff and procedures
- Strong initiative and willingness to take on new projects and learn new skills
- Strong understanding of ISO 9001 and 27001 requirements
- Team player with the ability to multitask and prioritize your work
- Strong verbal and written communication skills
- Exceptional organizational and time management skills
- The ability to thrive in a fast-paced environment
We’d also like you to have:
- A strong understanding of a regulated industry
- Quality management system experience - working with at least one of the 12 pillars of Quality
- Experience with managing multiple projects simultaneously
- Familiarity with Computer Software Validation and Computer Software Assurance
In addition to playing an important role in building Qualio, you'll receive:
- Competitive salary
- Flexible holidays
- Unlimited Time Off
- Professional development stipend
- Working space allowance / home office budget
- Opportunity to make a difference through helping life-saving products to get to market
Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications as described in a job description. We are committed to building a diverse and inclusive company and we are most interested in finding the BEST candidate for the job. That candidate may be one who comes from a less traditional background, and that’s okay. We would strongly encourage you to apply, even if you don't believe you meet every one of the qualifications described.
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