Manager, Quality Systems
About The Position
The Quality Manager leads quality improvement and implements and maintains quality practices for the facility’s product and service lines. The role is responsible for keeping site operations and quality systems compliant with applicable domestic and international standards, including ISO 9001, ISO 13485, MDSAP, CFR Parts 820 and 211, and EU MDR. The manager leads site initiatives in product and service quality, supplier quality, process quality, new product and service development quality, and quality system compliance. The position serves as the site’s Management Representative and ensures the quality system meets applicable regulatory requirements. This role leads the Quality staff, works with senior management to set quality strategy, supports manufacturing and servicing operations and Lean efforts, and drives continuous improvement through data analysis, projects, process capability, and quality metrics. It also oversees management reviews, production and process controls, complaint handling, quality input for product and service development, design assessments, and supplier qualification risk assessment. The role has authority over quality planning, personnel management, and regulatory compliance, and may perform the duties of Person Responsible for Regulatory Compliance (PRRC) for STERIS legal manufacturing entities under the EU MDR. The 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 of experience in a Quality leadership role.
- Must meet the experience requirements listed in Article 15 of the EU MDR for PRRC.
- Ability to travel domestically 10–20%.
- Excellent problem-solving skills.
- 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 desktop applications including Excel, Word, and PowerPoint.
Nice To Haves
- At least 8 years of experience in medical device or other regulated industries.
- ASQ or 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.
- Provide quality input 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 and international standards and requirements.
- Lead continuous improvement through 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 ensure 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, including quality risks and deliverables.
- Determine supplier qualification risks based on component criticality and supplier process capability.
- Conduct and direct quality planning, personnel management, and regulatory compliance activities.
- Perform PRRC duties on behalf of STERIS legal manufacturing entities under the EU MDR, as applicable.
- Perform other duties as assigned.
Benefits
- Market-competitive pay and eligibility for bonus participation.
- Extensive paid time off and additional holidays.
- Healthcare, dental, and vision benefits.
- Long- and short-term disability coverage.
- 401(k) with company match.
- Maternity and paternity leave.
- Add-on benefits and discounts, including pet insurance.
- Tuition reimbursement and continuing education programs.
- Opportunities for advancement in a stable, long-term career.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
