Global Quality Systems Specialist

Fortive • Irvine, CA

2d • Onsite

About The Position

Responsible to execute to the global Quality System requirements. This position reports to the leadership of Quality Systems.

Requirements

• Bachelor’s Degree.
• Minimum 3 years of experience in a quality or regulatory role in medical devices or related regulated industry.
• Equivalent combination of education and experience will be considered.
• In-depth knowledge of QMS and regulatory requirements.
• Excellent written and verbal communication skills (English).
• Demonstrated ability to train, mentor, and coordinate the work of others in daily operations.
• Seeks to deeply understand customer needs and prioritize work accordingly.
• Willing to take on the unknown and overcome adversity to support the goals of the business.
• Seeks varied perspectives and experiments with new ways of solving problems.
• Collaborates in support on team’s success.
• Demonstrates urgency and ownership to consistently deliver on objectives using FBS.

Responsibilities

• Manages document revisions, ensures compliance with formatting and approval workflows.
• Coordinate change control documentation and facilitate cross functional review.
• Analyzes change orders to ensure compliance to GDP requirements and existing procedures.
• Track and monitor quality systems metrics, including but not limited to: IE, CAPA and NC.
• Support timely documentation and closure.
• Assist in quality planning activities and QMS review preparation.
• Manage training assignments and monitor training metrics.
• Participate in internal audits and support audit readiness activities.
• Support internal audit logistics such as scheduling.
• Provide informal guidance to new team members.
• Solves problems in straightforward situations; analyzes possible solutions using technical experience and judgment and precedents.
• Explains complex information to others in straightforward situations.
• Collaborate with cross-functional teams to resolve issues.
• Collaborate cross functionally to support projects as assigned by direct manager.
• Responsible for communicating business related issues or opportunities to next management level.
• Supports continuous improvement initiatives.
• Internal interaction with cross-functional team members including Global teams.
• Minimal interactions with Regulatory Health Authority.
• Communication with customers requesting Quality System profile information.

Benefits

• We use the proven Fortive Business System (FBS) to accelerate our positive impact.
• We believe in you. We believe in your potential—your ability to learn, grow, and make a difference.
• We believe in us. We believe in the power of people working together to solve problems no one could solve alone.
• We believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating.
• Fortive: For you, for us, for growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level