Job Description
General Summary:
The Director ,Quality Engineering is responsible for leading quality improvement initiatives across the organization, focusing on the implementation and maintenance of structured problem-solving(Six sigma) methodologies, development, and management of KPI program, providing expertise in advanced root cause analysis, and providing statistical expertise. This individual will establish, maintain, and monitor Quality Key Performance Indicators (KPIs) and report on the performance of various Quality systems. The role involves leading business initiatives and critical investigations using Statistics and structured problem-solving techniques to improve quality outcomes.
This individual will demonstrate Vertex Core Values, as well as model leadership behaviors instilling a culture of quality, engagement, development, and transparency.
Key Duties and Responsibilities:
- Utilizing Six Sigma methods to drive process improvements and improve product quality.
- Establish, maintain, and support monitoring Quality KPIs across all Quality systems.
- Analyze and communicate data trends, offering insights and recommendations to senior management.
- Identify opportunities for enhancing data quality, addressing issues through error detection, correction, and process control.
- Promote a culture of continuous improvement within the organization.
- Establish and conduct advanced root cause analysis training for staff to enhance problem-solving capabilities.
- Conducts investigations for the resolution of complex quality problems.
- Develop and deliver training on structured problem-solving techniques.
- Drive innovation in quality engineering practices and tools.
- Provide statistical expertise across technical domains such as process control, design of experiments, and data analysis; review relevant statistical studies, regulatory standards, and emerging trends.
- Utilize a roadmap of continuous improvement for the organization by establishing priorities, methods for strategies, and implementation using data to both guide the process as well as monitor the result.
- Drive strategic initiatives aimed at elevating product quality and compliance.
- Lead and mentor other Quality personnel, ensuring user adoption and managing continuous improvement efforts.
Knowledge and Skills:
- Proven ability to lead and manage cross-functional teams, effectively communicate with all levels of management, and drive effective change.
- Working experience with 21 CFR 820 and ISO 13485 and other applicable regulations.
- Proficiency in data analysis tools and techniques (e.g., SQL, Excel, data visualization tools).
- Expertise with advanced statistical analysis and utilizing statistical software (SAS,R, JMP, Minitab etc.,)
- Strong oral, written and presentation skills with ability to explain complex concepts clearly to a variety of audiences.
- Understanding of industry requirements/expectations of a Quality Management System
- Current knowledge of industry trends and best practices- for progressive quality management in a regulated environment
- Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions.
- Experience working within a matrixed organizational structure and with global teams.
- Holistic understanding & experienced practitioner of Total Quality Management(TQM).
- Knowledge and experience in quality engineering, quality assurance, quality systems disciplines, and strategic leadership.
- Possesses a strong understanding of Quality engineering tools ( 8D RCCA, Statistical Process Controls, Lean Six Sigma, DoE) along with relevant industry standards and their application to drive execution excellence.
Education and Experience:
- M.S. or B.S. (or equivalent degree) and 10+ years of relevant work experience
- Six Sigma Black Belt Certification is required
#LI-hybrid
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
