Software Quality Manager
Irvine, CA

Job Description

At Fortive, we believe in you. We believe in your potential - your ability to learn, grow, and contribute in meaningful ways.

We believe in the power of great people working together to innovate and solve problems no one could solve alone. We build enduring partnerships with our customers and take on their challenges and opportunities as our own.

Position Summary:

This Quality System (QS) Manager is responsible for the leadership and oversight of the ASP Computer Software Validation Team. This role shall support Software Design Life Cycle (SDLC) of business systems and quality systems to ensure compliance with SDLC procedures, regulations, and standards.

In accordance with all applicable government laws, regulations, standards, and ASP Quality Manual and procedures, this position shall:

* Hire and maintain resources with the appropriate education, training, and experience to carry out job duties and responsibilities.
* Provide daily leadership and management for the CSV Team.
* Establish, maintain, and improve SDLC procedures and processes.
* Act as CSV subject matter expert and resource leader for CSV to deliver results.
* Work in a cross-functional environment to support SDLC projects of business systems and quality systems.
* Lead, influence, and negotiate to achieve business strategies and deliver results on time.
* Communicate business related issues and sopportunities to senior management.
* Ensure SDLC projects are documented and provide a high degree of assurance the systems will consistently and continually meet the validated requirements.
* Serve as technical expert of CSV for the organization.
* Represent QS CSV during regulatory inspections and notified body audit.
* Provide inspection support; inspection readiness, execution (front room and back room) and post inspection activities.

Education:

Required Minimum Education 1 or Equivalent

Bachelor of Art or Science Degree

Preferred degree in Computer Science, Engineering, Life Sciences, or Physical Sciences

Years of Related Experience:

5 Years, experience in SDLC is required

3 Years, experience in regulated industry; medical device or pharmaceutical is preferred

2 Years, experience in management is preferred

Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:

(Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)

* Knowledge of 21 CFR Part 820 and Part 11, ISO 13485 and ISO 14971, MDD/IVDD, EU MDR,
* Experience in SDLC within medical device or pharmaceutical industry
* Experience in CSV within medical device or pharmaceutical
* Experience supporting regulatory inspections and audits (i.e. FDA or Notified Body)
* Experience in quality management systems databases (i.e. Trackwise, EtQ, Mastercontrol)
* Experience in Microsoft Office (i.e. Word, Excel, and PowerPoint)
* Ability to work in a self-directed environment and team environment
* Ability influence across functional areas and make change
* Skilled project manager and change management
* Critical thinker, detailed oriented, organized, and collaborative
* Excellent written and oral communication skills
* Strong leadership and coaching skills