Quality Manager

Job Summary

The Quality Manager is responsible for the Quality function and related operations at a Safeguard site to ensure compliance with regulatory standards, company policies, and industry best practices. This role is critical in maintaining the effectiveness of the Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable international regulations. The Quality Manager will lead and manage the overall QA team, including Quality Engineers, technicians, and QC inspectors; and will coordinate with cross-functional departments to uphold the quality of medical device products from development through post-market while developing team members and fostering a culture of compliance within Safeguard Medical.

Essential Job Functions

• Manage and lead a team of quality engineers, technicians and QC inspectors, providing guidance, training, and support to ensure their professional development and performance 
• Ensure quality assurance and quality control activities are carried out effectively
• Drive a culture of compliance through influence, relationships, and partnerships with cross-functional leaders
• Support and execute quality activities in relation to Operational support including support of risk management creation, classification of quality characteristics, technical drawings and specifications, design verification and validation, and process validation activities
• Oversee testing and validation processes, as necessary, including protocol and report development or review, to ensure compliance with quality standards
• Monitor and analyze quality metrics and performance indicators to identify trends, areas for improvement, and opportunities for process optimization 
• Conduct or participate in risk management activities and implementing risk management strategies to identify and mitigate potential quality issues for new and existing products and processes
• Oversee the management of customer complaints ensuring that they are investigated, analyzed, and resolved in a timely manner, as well as CAPAs to address root cause and prevent recurrence of quality issues
• Supports supplier management principles such as supplier selection, qualification, certification, and performance improvements, including execution of control measures and resolution activities when supplier quality issues are identified
• Review Change Orders and assess quality impact of product and process changes
• Promotes a culture of continuous improvement within the department and the broader company 
• Proactively drive activities to meet and/or exceed company objectives
• Establish and maintain quality control procedures, including inspection/control plans, testing protocols, and documentation requirements
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality considerations are integrated into new product development, and manufacturing processes
• Lead or participate in internal and external audits to assess compliance with quality standards and regulatory requirements.
• Uses appropriate statistical tools such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying Statistical Process Controls (SPC), identifying relationships between variables, and statistical decision making
• Support activities related to clean room monitoring and environmental controls
• Collaborate with suppliers, contract manufacturers, and the internal supply chain team to ensure adherence to quality standards and specifications, while applying supplier management principles such as supplier selection, qualification, certification, and performance improvement, traveling to such partners when necessary 
• Develop and validate test methods while applying metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices, conduct measurement system error studies such as Gage R&R
• Apply the concepts of producer and consumer risk, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc., interpret and select variable, attribute, and zero-defect sampling plans
• Keep up to date with industry trends, regulatory changes, and best practices in quality assurance and engineering for medical devices, and implementing necessary updates to the quality management system
• May act as project lead for functional and cross-functional projects, including generation of the project definition, plan, and requirements
• Ensure quality of the company’s products through the establishment, monitoring, and enforcement of a Quality Management System in compliance with ISO 13485, EU Medical Device Regulation (MDR), UK MDR, and US 21CFR820 requirements, as well as 21CFR210 and 211 where appropriate.  
• Act as the Management Representative and Person Responsible for Regulatory Compliance (PRRC) for the Safeguard site, as necessary 
• Perform other related duties and responsibilities as assigned

Qualifications:

• Bachelor's degree in a scientific or related field
• Minimum of 5 years of experience in quality engineering for medical devices
• Strong understanding of quality management systems, regulatory requirements, and industry standards specific to medical devices, including a working knowledge of 21 CFR 820, EUMDR, ISO 13485:2016, ISO 14971:2019 and IEC 62366-1:2015 
• Strong understanding of the product development process
• Extensive experience with root cause analysis and statistical data analysis
• Establishes and fosters an environment of strong collaborative relationships with internal, cross-functional partners, suppliers, and service providers.
• Demonstrated ability to manage and prioritize assigned project tasks to deliver on-time, on-quality, and on-budget
• Oversees or participates in the development and execution of detailed validation test protocols 
• Experience with sterilization and packaging validation activities preferred
• Excellent leadership, communication, and problem-solving skills to effectively manage a team and drive continuous improvement in quality processes and outcomes
• Detail-oriented with strong organizational and project management skills
• Strong attention to detail and ability to work in a fast-paced environment
• Demonstrated ability to collaborate effectively with cross-functional team members
• CQE Certification preferred
• Minitab experience preferred.
• Certified ISO 13485 auditor preferred
• Six Sigma/Lean Certification preferred
• Consistently demonstrates and upholds the culture and values of the organization internally and externally. Must fit within the Safeguard Medical culture

Competencies 

• Self-directed, demonstrating ownership and accountability with an aptitude and willingness to learn 
• Collaborative personality with the ability to lead and influence others effectively while creating and maintaining a positive environment 
• Excellent critical thinking skills, including experience implementing the DMAIC thought process and structured root cause analysis. ability to independently make sound decisions with available information; ability to analyze data using statistical methods
• Respect for people with a desire to develop junior-level team members including coaching in 1:1 and team settings
• Ability to perform at high levels in a thriving environment, preferably in the medical device industry or combination products industry
• Understanding of change management, conflict resolution and team dynamics 
• Ability to identify project and design risks and create mitigation strategies 
• Knowledge of ISO regulations/standards, FDA and EU MDR regulations
• Ability to focus and achieve scheduled milestones, including contingency planning.
• Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
• Strong team-working and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed.

Physical Requirements 

Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping and reaching. Vision requirements include the ability for close vision, to adjust focus, to color code.  

Mental Requirements 

This position requires the ability to maintain an appropriate work pace; to comprehend and follow instructions; to read, count and compute; to exercise logic and reasoning; to organize and prioritize; to problem solve; to make decisions; to analyze and interpret data; to multi-task/re-direct and experience numerous interruptions.  

Other Requirements 

• Estimated travel requirement: Less than 15% 
• Must fit within the Safeguard Medical culture 

Work Environment 

The noise level in the work environment is usually quiet to moderate when working in the office and moderate to loud when working in the production setting. 

This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned and activities may change at any time with or without notice.

Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. 

Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool.