Job Description
The Senior Global Quality Systems Specialist has the responsibility to execute to the global Quality System requirements. This position reports on the leadership of Quality Systems.
Your Impact
Here’s where you’ll demonstrate your competencies:
Facilitates change control review meetings and cross-functional alignment on product changes.
Analyzes change orders to ensure compliance to GDP requirements and existing procedures.
Lead global issue escalation forums and facilitate cross-functional resolution of high-impact issues.
Monitor Quality Systems metrics, including but not limited to: Audits, IE, CAPA, and NC
Assist in quality planning and contribute to QMS review meetings.
Conduct Quality Systems training sessions and evaluate training effectiveness.
Execute training strategy and facilitate feedback and improvements.
Lead and execute internal audits while providing support for external audits conducted across ASP sites.
Act as a resource for colleagues with less experience.
Solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information
Explains difficult or sensitive information; works to build consensus for quality initiatives
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
Perform other duties as assigned.
Our Needs
Here’s what we’ll need from you:
Bachelor’s degree in engineering, science, or related field.
Minimum 5 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
Your Impact
Here’s where you’ll demonstrate your competencies:
Facilitates change control review meetings and cross-functional alignment on product changes.
Analyzes change orders to ensure compliance to GDP requirements and existing procedures.
Lead global issue escalation forums and facilitate cross-functional resolution of high-impact issues.
Monitor Quality Systems metrics, including but not limited to: Audits, IE, CAPA, and NC
Assist in quality planning and contribute to QMS review meetings.
Conduct Quality Systems training sessions and evaluate training effectiveness.
Execute training strategy and facilitate feedback and improvements.
Lead and execute internal audits while providing support for external audits conducted across ASP sites.
Act as a resource for colleagues with less experience.
Solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information
Explains difficult or sensitive information; works to build consensus for quality initiatives
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
Perform other duties as assigned.
Our Needs
Here’s what we’ll need from you:
Bachelor’s degree in engineering, science, or related field.
Minimum 5 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
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