QA CAPA and Complaints Manager
in US - WA - Snoqualmie
At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology 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 QA CAPA & Complaints Manager is responsible for managing the quality system Corrective and Preventive Action (CAPA) and complaint functions. Specifically, compliance functions relating to the coordination, oversight and corrective action responses relating to FDA inspections and ISO audits. The QA CAPA & Complaints Manager must be well versed in FDA and ISO quality system requirements.
- Manage quality systems activities for Spacelabs Healthcare.
- Manage implementation of the Quality Management System; specifically associated with CAPA and complaints, supporting procedures and required responses to inspections and audits.
- Assist in structuring the Spacelabs Healthcare quality management system to achieve corporate objectives in the most effective and efficient manner.
- Harmonize and integrate processes in partnership with other Quality Managers.
- Oversee upgrades and maintenance of CAPA and Complaints tool processes and associated schedules.
- Engage in continuous process improvement through measurement and evaluation.
- Implement process improvements to achieve consistent and predictable result.
- 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, preferably in science or engineering (4 years of directly related experience may be substituted for the educational requirement).
- 5+ years of experience with medical device regulatory quality systems and/or direct FDA experience.
- Proficiency with Microsoft Word, PowerPoint, Outlook, and Excel.
- Creative problem solving, flexibility, and good negotiation skills.
- Proven ability to communicate effectively with staff at all levels of the organization.
- Proven ability to deliver results through others, both direct and matrixed. Proven ability to lead, develop, motivate and hold others accountable.
- Ability to manage multiple, complex priorities within demanding timeframes. Strong project management skills. Strong organizational and time management skills.
- Excellent interpersonal and communication skills written and verbal, demonstrated by the ability to: listen to and empathize with others; convey confidence; provide exemplary levels of service; resolve conflict effectively; collaborate with and facilitate small groups. Exceptional writing and oral communication skills – be able to make complex information into clear executive summaries for diverse audiences.
- Minimum of 3 years’ experience managing people.
- Able to execute tactically while still thinking strategically.
- Experience working positively and productively in a team environment. Highly collaborative.
- Use of computer: 50%.
- Travel: Some domestic travel is required <5% May travel internationally and be able to acquire all necessary travel documents.
- Must be able to complete job responsibilities working with global time zone needs such as attending late night/early morning meetings by phone and/or web to meet global business needs: 15%.
Equal Opportunity Employer
EEO is the Law
OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for the Security and Healthcare divisions, as well as to external original equipment manufacturer clients for application in the defense, aerospace, medical and industrial markets, among others.