At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcaretechnology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients.
Why work at Spacelabs? Because lives depend on you!
The Manager Quality Systems manages document control, device configuration, and the Unique Device Identifier (UDI) program. These activities include: ensuring compliance to applicable standards and regulations associated with these functional areas, process development and maintenance, and employee development and management.
- Functions as the Spacelabs Device Master Record owner.
- Manages Spacelabs configuration control system; functions as the System Administrator.
- Establishes Spacelabs Document Control processes, and establishes Spacelabs Good Documentation processes. Works with Training and functional management to ensure practices are implemented.
- Establishes group goals and objectives as well as cross-functional goals and objectives; ensures progress towards goals is met.
- Establishes and manages Spacelabs Unique Device Identifier (UDI) program; manages UDI processes and system applications.
- Establishes Spacelabs device configurations.
- Functions as the Spacelabs Subject Matter Expert for Document Control and the UDI program.
- Establishes and maintains quality programs and systems to support corporate quality policy, regulatory requirements, and quality objectives.
- Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork.
- Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the Company’s values, Code of Ethics and Conduct, and applicable compliance policies.
- Manage, evaluate and develop team of employees to meet functional deliverables and responsibilities. Complete company people management requirements. Exhibit manager core competencies.
- It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
- Duties may be modified or assigned at any time to meet the needs of the business.
- Bachelor’s degree in business, sciences, quality management or related field, or equivalent professional experience.
- 2+ years of experience with direct management of employees
- 5+ years of experience in document control and/or working with quality systems in a highly regulated industry.
- 2+ years of experience in the medical device domain required.
- Expert level working knowledge of medical device software applications.
- Experience with Agile Product Lifecycle Management software; experience as an Agile Product Lifecycle Management Administrator preferred.
- Working knowledge of Good Documentation Practices (GDP).
- Proficient with Microsoft Office tools.
- Must be detailed oriented. Ability to manage multiple, complex priorities within demanding timeframes. Strong project management skills.
- Excellent communication and presentation skills (listening, written and verbal) in English.
- Ability to communicate at all levels of an organization effectively.
- Technical writing experience is a plus.
- Understanding of Medical Device Quality Systems including procedures and work instructions a plus.