What’s the opportunity?
Do you enjoy working with people, solving problems, and going above and beyond for customers? Do you have a “get stuff done attitude” and are looking to join a great team that offers flexibility and balance? Do you enjoy working cross functionally, as well as customer facing? We are searching for a quality specialist with the right blend of life sciences industry experience, as well as computer tech savvy.
As a Quality Specialist for Qualio, you will be assisting the Quality group in managing Qualio’s quality system compliance activities, as well as helping our customers with their quality systems.
What will I be doing?
You will be supporting our customer base with their implementation and management of their quality systems through our additional services offerings. You will also be helping Qualio in building and maintaining its internal quality system.
To be successful in this role, you should be an excellent communicator who is able to earn trust both with customers and your teammates, as well as being comfortable communicating with all levels of an organization. You should have a solid working knowledge of the life sciences industry and have spent time at a drug or device company responsible for various aspects of their quality activities.
As a Quality Specialist, you will...
- Manage and administer an ISO 9001 quality system for our internal compliance.
- Establish and support quality systems that are FDA/ISO compliant for a variety of drug and medical device customers under ISO, QSR, and GMP regulations.
- Keeping up on the various regulations applicable to Qualio and its customer base
- Other duties as required
What skills do I need?
- 3-5 years of experience in Quality Specialist role in the Life Sciences space;
- Strong technical skills and understanding of software systems and their use in quality activities;
- Strong initiative and willingness to take on new projects and learn new skills;
- Team player with the ability to multitask and prioritize projects and customer needs;
- 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:
- Experience with all aspects of an eQMS system;
- Some familiarity with regulations in other countries - MDR, PICS, etc.
- Experience with managing multiple projects simultaneously.
...And be aligned to our values:
- Seek Ownership - We thrive on being trusted, on freedom, and on being able to make an impact. We live up to verbal and written commitments, and adjust quickly to changing priorities
- Customer-centric - We prioritize creating a positive customer experience with every decision and every action.
- Always Curious - We are voracious learners, open to new ideas and can integrate them into our professional and personal lives quickly.
- Intentional communication - We believe in running an open company that communicates early and often, with a focus on clarity.
- Team players - We earn trust and support each other. We seek what is best for the company, rather than what is best for ourselves or our group.
In addition to playing an important role at Qualio, you'll receive:
- Generous health and retirement benefits;
- Competitive salary;
- Unlimited PTO;
- Distributed, office-agnostic work environment;
- And make a real difference through helping life-saving products to get to market.