Manager, Quality Systems

STERIS•Cooper City, FL

8d•Onsite

About The Position

The Quality Manager leads quality improvement and quality-system compliance for STERIS’s Cooper City, Florida facility. The role is responsible for implementing and maintaining quality practices for the facility’s product and service lines and ensuring that operational and quality systems comply with applicable domestic and international standards, including ISO 9001, ISO 13485, MDSAP, CFR Part 820/211, EU MDR, and other applicable requirements. The manager leads site efforts in product and service quality improvement, supplier and process quality, new product and service development quality, and quality-system compliance. The position serves as the site’s Management Representative and is responsible for ensuring that the quality system meets applicable regulatory standards. The role provides strategic direction for quality strategies and tactics in collaboration with site senior management, and leads, coaches, and mentors Quality staff. It also leads management reviews, continuous-improvement activities, production and process controls, complaint handling, and quality input into product development and supplier qualification. The position has authority to conduct and direct quality planning, personnel management, and regulatory-compliance activities, and may perform the duties of Person Responsible for Regulatory Compliance (PRRC) for STERIS legal manufacturing entities under EU MDR. This position is onsite in Cooper City, Florida, during core business hours and requires 10–20% domestic travel.

Requirements

Bachelor’s degree in Engineering or a related field.
At least 8 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
At least 8 years of experience working in an ISO-certified environment.
At least 2 years in a Quality leadership role.
Must meet the experience requirements in Article 15 of the EU MDR for PRRC duties.
Ability to travel domestically 10–20%.
Excellent problem-solving skills and a focus on identifying potential issues and continuous improvement.
Experience working on cross-functional teams and independently.
Excellent organizational, oral, and written communication skills.
PC experience and working familiarity with Excel, Word, and PowerPoint.

Nice To Haves

At least 8 years of experience in medical devices or other regulated industries.
ASQ certification, QSR certification, or familiarity with QSR/GMP regulations.
Experience with statistical analysis software and Visio.

Responsibilities

Lead Quality staff to ensure compliance with the Quality Management System and drive continuous improvement.
Align quality activities with manufacturing and servicing operations, support Lean efforts, and improve product and service quality.
Work with site senior management to develop quality strategies and tactics, and provide quality perspectives on future product and service development.
Coach, mentor, and lead Quality staff.
Serve as the site’s Management Representative and lead the Management Review process.
Ensure compliance with applicable domestic regulatory requirements and international standards.
Lead continuous-improvement activities, including data analysis, improvement projects, and process-capability work to improve quality-dashboard metrics.
Lead and implement effective production and process controls.
Manage complaint handling to support customer responsiveness and product and process improvements.
Ensure compliance with the New Product Development process and that Product Requirements Documents include key quality performance metrics.
Assess new designs for manufacturability, testability, and reliability, and ensure quality risks and deliverables meet application reliability and design intent.
Determine supplier-qualification risks based on component criticality and supplier process capability.
Conduct and direct quality planning, personnel management, and regulatory-compliance activities, including PRRC duties under EU MDR where applicable.
Perform other duties as assigned.