This position will be within the Corporate Preclinical Development and Toxicology Quality Assurance Unit. It will conduct nonclinical laboratory investigations of medical devices and materials per GLP regulations and the CPDT Quality System.
Quality Assurance strives to live values as part of an action-oriented team focusing on customer requirements and process effectiveness through continuous learning, influencing others, and dedication to achieving the highest quality results.
The Staff Quality Systems Specialist II ensures quality oversight of preclinical testing, including GLP phase audits of internal and external testing completed as part of a GLP-compliant study. The program includes toxicology and biocompatibility, focusing on sizeable complex animal models for surgical and interventional procedures. The Staff Quality Systems Specialist II interacts with both internal and external stakeholders to ensure compliance of preclinical studies to the GLP regulations (21 CFR Part 58) and internal procedures.
The Staff Quality Systems Specialist II is accountable for support of the continued development, improvement, and implementation of the Quality Systems. This position actively participates in quality guidance and problem-solving techniques to promote New Product Development and support project teams for process improvement and continuous improvement activities. We are the makers of possible.
One of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams allows us to evolve continually. Join us and discover an environment where you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
Primary Responsibilities and Duties:
Responsibilities:
1 Responsible for utilizing and developing phase and systems audit programs for internal laboratory functions and external suppliers in direct support of 21 CFR Part 58, ISO 17025, and the overall Quality System. Quality Assurance Unit, documentation/activity support, applies to most aspects of the systems employed by CPDT for material risk assessments, material characterization, and internal/external GLP biocompatibility testing for medical devices as described in ISO 10993 and FDA G95-1.
2 Active Participation in developing, implementing, and maintaining various aspects of the CPDT Quality System, including creating and reviewing documents (SOPs, Procedures, Methods, and Protocols) to support continual quality improvement.
3 Acts as Lead QAU for multi-site studies and works with QA management to ensure there is adequate QAU coverage for all aspects of a GLP study.
4 Support the CPDT Training System to ensure training is performed and documented to maintain compliance with the Quality System and regulatory requirements.
5 Accompany representatives from sponsoring organizations or government regulatory agencies during site audits.
6 Responsible for GLP and Quality System training.
7 Responsible for maintaining the Master Schedule.
8. Collaborates with staff to identify, evaluate, and recommend solutions to audit findings during the performance of quality audits.
9 Assist in managing the supplier audit and approval system, including setting audit dates with suppliers and performing audits.
10 Collaborate with managers, scientists, and Quality Assurance personnel to develop process improvements to enhance testing and workflow efficiency.
Minimum Requirements:
- Bachelor’s degree in scientific discipline plus five years of experience with large animal GLP testing
- High level of application of Quality System Standards to assigned Quality system area.
- Working Knowledge of Quality Systems Regulatory requirements and application to Company/Unit requirements
- Direct knowledge of 21 CFR Part 58 and Preclinical Functionality Testing, including designing compliance strategies to support successful regulatory submissions.
- Demonstrated ability to work successfully independently as well as part of a team.
- Excellent verbal and written communication skills.
- Must be able to focus and execute multiple projects and programs simultaneously while maintaining attention to detail.
- This position requires excellent organization and the ability to adapt rapidly to changing priorities in a high-volume scientific testing laboratory.
- Must be able to travel to audit suppliers and site locations for audit-related site visits.
Employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great; we do what’s right, hold each other accountable, and learn and improve daily.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory while leaving a legacy simultaneously. And through the organization’s investment in University, you will continually level up your tech skills and expertise.
To find purpose in the possibilities, we need people who can see the bigger picture and who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At , you’ll discover a culture where you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
An Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate based on race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.