Manager of Quality Systems

The Automation Partnership (Cambridge); Yauco (PR); On-site; USD 100,000 - 170,000; Full time

Job summary

The Automation Partnership seeks a Manager of Quality Systems to oversee the site Quality Management System, ensuring alignment with Sartorius standards and regulatory requirements. You will drive systematic analysis of customer complaints, lead KPI reporting, and coordinate audits to uphold quality.

Lead calibration programs, CAPAs, and document control; develop strategies to reduce defects, improve processes, and sustain a culture of quality.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• Minimum of 10 years in a GMP-regulated environment, preferably medical devices.
• At least 5 years of leadership or supervisory experience managing cross-functional teams.
• Hands-on experience in managing Quality Systems (CAPA, Change Control, Document Control, Complaints).
• Strong knowledge of ISO 9001, ISO 13485, and FDA requirements.
• Proven ability to lead audits (internal, customer, regulatory).
• Experience with KPI-driven quality performance management and continuous improvement.

Responsibilities

• Audit management and compliance leadership across customer, internal, and regulatory audits.
• Maintain ISO certifications and regulatory alignment (ISO 9001, ISO 13485, FDA).
• Manage customer observations and complaints with timely resolutions.
• Lead root cause analysis and CAPA activities to closing within targets.
• Develop strategies to reduce customer complaints and ensure 30-day closures.
• Oversee CAPA, Nonconformance, Change Control, and Document Control processes.
• Monitor KPIs, drive improvements, and reporting to leadership.
• Lead and develop the Document Control and Complaint Handling teams.

Skills

GMP experience

Leadership

Audit management

CAPA & Change Control

KPI-driven management

Complaint handling

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in Engineering / Life Sciences

Advanced degree preferred

Job description

The Manager of Quality Systems is responsible for overseeing and maintaining the effectiveness of the site's Quality Management System in alignment with Sartorius standards and applicable regulatory requirements. This role ensures systematic management and analysis of customer complaints, driving structured problem-solving and continuous improvement initiatives. The position leads the definition, monitoring, and review of key performance indicators (KPIs), facilitating KPI-driven meetings to reinforce a quality-focused culture, improve processes, and measure performance outcomes. Additionally, the role is accountable for the oversight of equipment and instrument calibration programs to ensure accuracy, compliance, and operational reliability. The Manager of Quality Systems also serves as the primary lead for customer audits, ensuring readiness, coordination, and effective execution. This includes the management of audit outcomes through the implementation of corrective and preventive actions (CAPAs) to address findings and strengthen the overall quality system.

Grow with Us - Your Responsibilities

• Audit Management & Compliance Lead and oversee all customer, internal, and regulatory audits, ensuring full compliance with applicable standards and timely closure of findings.
• Maintain and continuously improve compliance with certifications including ISO 9001, ISO 13485, and RX-360.
• Customer Quality & Complaint Handling Ensure all customer observations and complaints are effectively communicated, assigned, and resolved within defined timelines.
• Drive robust root cause analysis and corrective actions to achieve timely complaint closure in accordance with company standards.
• Develop and implement strategies to achieve zero customer complaints and ensure closure adherence within 30 days.
• Quality Systems Oversight Own and manage core Quality System processes including CAPA, Nonconformance (NCPR), Change Control, and Document Control.
• Monitor system effectiveness through KPIs and metrics, driving continuous improvement initiatives.
• Ensure proper governance and lifecycle management of controlled documents.
• Leadership of Quality Functions Manage and develop the Document Control and Complaint Handling teams to ensure operational excellence and compliance.
• Foster a culture of quality, accountability, and continuous improvement across the organization.
• Calibration & Operational Support Oversee the site-wide calibration program to ensure accuracy of measurement systems and regulatory compliance.
• Collaborate with Manufacturing and cross-functional teams to enhance product reliability, efficiency, and cost-effectiveness.
• Continuous Improvement & Performance Management Identify opportunities to reduce waste, improve efficiency, and optimize quality processes.
• Define, track, and report key quality KPIs to drive performance and informed decision-making.
• Develop action plans to reduce CAPA and NCPR volumes and improve overall system effectiveness.
• Customer & Employee Experience Support customer satisfaction initiatives and internal engagement programs, driving measurable improvements.
• Act as a key advocate for quality excellence in both customer-facing and internal processes.
• Strategic Quality Planning Establish and maintain quality objectives aligned with business strategy and regulatory requirements.
• Ensure alignment of quality goals with production processes to support scalability, compliance, and operational excellence.

What Will Convince Us

• Bachelor's degree in Engineering, Life Sciences, or a related discipline (advanced degree preferred).
• Minimum of 10 years of progressive experience within a GMP-regulated environment, preferably in the medical device industry (21 CFR Part 820).
• At least 5 years of leadership or supervisory experience managing cross-functional teams.
• Demonstrated hands-on experience in managing and improving Quality Systems (e.g., CAPA, Change Control, Document Control, Complaints).
• Strong knowledge of global quality regulations and standards, including ISO 9001, ISO 13485, and FDA requirements.
• Proven ability to lead audits (internal, customer, and regulatory) and ensure sustained compliance.
• Experience in KPI-driven quality performance management and continuous improvement methodologies.
• Strong leadership skills with the ability to develop, coach, and motivate teams in a dynamic environment.
• Results-oriented mindset with a focus on accountability, operational excellence, and continuous improvement.
• Effective communication and stakeholder management skills across all organizational levels.
• Demonstrated ability to identify improvement opportunities and drive efficiency, cost reduction, and process optimization.
• Strong analytical and problem-solving skills with a data-driven decision-making approach.
• Thrives in a dynamic, fast-paced, and innovative environment.
• Proactive, adaptable, and motivated to contribute to company growth.
• Committed to excellence, collaboration, and being recognized as a sub