Title: Global QMS Document and Change Controls Administrator
Location: On site, Lakewood, CO/Hybrid: 2 days remote after training
Schedule: M-F 8:00-5:00/ 7:30-4:30
Pay: $92-124k, 7% bonus, excellent healthcare benefits, unlimited PTO
Type: Direct/Permanent
Start date: Immediate

Overview:
Our client a global medical device company, is currently seeking qualified candidates for the position a global leader to be the Global QMS Document and Change Controls Administrator who is responsible for providing Quality Management System (QMS) leadership to monitor, maintain, and continuously improve processes and supporting technology with respect to Quality Management System (QMS) Elements.

Responsibilities:
•    Serves as the global process owner and a subject matter of expert for global regulations, standards, and processes within the QMS area of expertise.
•    Spearheads the global process consistent with regulatory and industry best demonstrated practices. 
•    Strategically plan and set the stage for future improvements within the QMS. 
•    Collaborates with regulatory affairs function to stay informed about changes in regulations and updates processes accordingly. 
•    Collaborates with cross-functional teams to understand and document needs across various departments and regions.
•    Understands change management and drives changes to align with best demonstrated practices. 
•    Communicates effectively with stakeholders to be able to influence and create a solid understanding of the QMS process.
•    Establishes key performance indicators (KPIs) to measure the effectiveness of the quality system element.
•    Develops process workflow and procedure improvements to deploy, teach and coach teams across the globe.
•    Develop and maintain training material to ensure compliance of the QMS Element training program.
•    Responsible for communication and coordination with business functions, site process owners and site leadership for implementation of process and applicable technology changes.
•    Effectively manages, resolves and/or escalates QMS-related implementation and/or interpretation issues in a timely fashion for quick resolution.

Requirements:
•    Bachelor's degree in a relevant engineering or scientific field required. 
•    Minimum 10 years of experience in Quality, Regulatory Affairs, Manufacturing or Engineering within regulated industry (medical device or pharmaceutical).
•    Knowledge and experience interpreting and applying global regulations and standards for QMS (FDA, ISO, EU MDR and/or quality requirements associated with developing medical devices and combination products). 
•    Demonstrated experience working with, influencing and/or leading global teams required. 
•    Experience working with electronic document management systems required.
•    Experience working in a manufacturing environment is highly preferred. 
•    Knowledge and experience working within a Quality Management System, integration of QMS elements and expectations of the organization to meet QMS requirements.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.