The Manager - Quality Management Systems will lead operational excellence and competency building for corporate quality programs, ensuring high-quality culture through standardized and auditable means. This role involves establishing and managing a global product and client quality assurance program, driving continuous improvement projects, and supporting global industrial initiatives. Key responsibilities include assessing operational excellence, owning product quality metrics, identifying product improvement solutions, establishing and enforcing quality assurance procedures, managing risks, collaborating with regulatory teams, and driving continuous quality improvement through data analysis. The manager will also oversee product and client quality management processes, implement tools like Quality Risk Management, and ensure proper change management for validated processes.
Required Skills
Soft Skills & Professional Competencies
○Leadership○Team Building○Team Development○Problem Solving○Root Cause Analysis○Communication○Presentation Skills
Business, Sales & Management
○HR Management
Information Technology
○Quality Assurance○Software Engineering○Python○UML○Accessibility○Power BI
comprehensive benefits, global benefits like adoption and surrogacy assistance, parental leave, programs that support mental, emotional, physical, and financial well-being, competitive pay, medical, dental, and vision insurance, 401(k) plans with company match, paid time off, alongside other meaningful employee offerings. Management is also eligible for bonus.
Requirements
Requires a Bachelor of Science in Engineering or a Technical discipline, or 5+ years of equivalent experience. Must have strong leadership, working knowledge of Quality Management Systems, experience in problem-solving and quality assurance processes (including root cause analysis), coding familiarity (Python, MATLAB, VBA), core engineering concepts (mechanical analysis, material science), strong English communication skills, and proficiency in Microsoft Office suite and Power BI. Experience in data integration is preferred.
Description
The Manager - Quality Management Systems will be responsible for Process Quality Assurance by setting standards and discipline for corporate quality programs through operational excellence, competency building, strategy, and innovation. This will include assessing standardized and auditable means of maintaining a high-quality culture. The Manager will establish an effective Product and Client Quality Assurance program to support our clients globally. They will drive continuous quality improvement projects, global harmonization initiatives, and support global Industrial initiatives. In addition, this role will provide successful cross functional leadership, develop, implement and evaluate the Quality resources of the Quality Assurance and Quality Control (QA/QC), and customer quality strategies in alignment with the Corporate’s business strategy, the Supply Chain’s business objectives, the Global Quality’s direction, and the capacity.
Key Accountabilities
Assess operational excellence and competency and identify actions to close the gaps.
Own the product quality assurance metrics and the quality data.
Utilizing the quality data, identify product improvement solutions, recommend potential modification in design, manufacturing process or test methods to meet requirements and to eliminate product issues proactively.
Establish, update, maintain, and enforce quality assurance procedures and methods to comply with applicable industry requirements, regulatory requirements, and customer expectations.
Identify risks of failure in the system, evaluate and create policies to reduce those risks in the effort to improve sustainable quality.
Collaborate with the Product Regulatory and Compliance team to ensure compliance to applicable regulations in Quality policies and procedures.
Responsible for data analysis of the quality performance trends and driving continuous quality improvement projects. Use data to drive improvement through disciplined metrics.
Ensure effective management of Product and Client Quality Management processes including assuring effective management reviews, client quality issue management, CAPA system, change control, design quality and product quality support to the retails.
Develop and implement processes and tools such as Quality Risk Management (QRM), supplier assessment/audit, and deviation trend management.
Assure proper use of change management associated with validated processes.
Recommend continuous quality improvement projects and global harmonization initiatives.
Provide cross functional Leadership, develop, implement and evaluate Process Quality Assurance resource (QA and QC) and operational strategies in alignment with the corporate’s business strategy, the Supply Chain’s business objectives, the Global Quality’s direction, and capacity.
Remain current with industry standards and advanced analytics in quality.
Maintain clear communication paths with stakeholders and foster effective cross-functional partnership.
Required Qualifications
Bachelor of Science in an Engineering or Technical discipline or 5+ years equivalent related experience.
Strong leadership in team building and development.
Working knowledge of the principles and the purpose of a Quality Management System.
Experience in problem solving and hands-on working knowledge of quality assurance processes and tools, such as root cause analysis.
Experience coding, including familiarity with basic software like Python, MATLAB, or VBA.
Strong knowledge in core engineering concepts such as mechanical analysis, and material science.
Strong communication skills (English written, verbal and presentations skills).
Proficient Microsoft Office computer skills (specifically Excel, Power Point, Word, Visio, Power Apps and Access) and Power BI.
Preferred Qualifications
Experience in data integration.
The hiring range for this position ranges from $122,500 - $150,000. The rate of pay offered will be dependent upon candidates’ relevant skills and experience. Management is also eligible for bonus.