Integra LifeSciences Director, Global CAPA and Nonconformances in Mansfield, Massachusetts
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The Director, Global CAPA and Nonconformances will develop and lead the implementation plan of Integra’s Global Quality Management System Compliance Processes (CAPA and Nonconformances). Work with process and Quality Operations leadership to drive consistent best practices for CAPA and Nonconformances, Management Review and Metrics and establish global oversight. Deploy CAPA and Nonconformance processes and digital systems that improve compliance, efficiencies, and overall effectiveness. Responsible for partnering with global quality leaders to develop processes and metrics that result in attaining the company’s improvement objectives and growth strategies.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Develop and Establish Integra’s scalable Nonconformance and CAPA Programs. Create the standard for CAPA and NC performance. Identify mechanism/measures for early detection of process failures. Pulling in industry best practices.
Deploy CAPA coaching program to establish gold standard for CAPA coordinators across Integra sites.
Global Process owner for CAPAs, Nonconformances and Metrics (execution of the corporate CAPA, NC and metrics, standardization of processes and systems for CAPA, NC and metrics)
Drive standardization & deploy world-class solutions to drive improved quality and compliance.
Establish a Global Corrective and Preventive Action (CAPA) Program, including governance and oversight, to ensure compliance and consistency in areas of investigation, effectiveness, timeliness, quality and thoroughness of content. Collaborate with process owners and stakeholders in corporate, division and site to ensure the program is compliant, executable, and meets user needs.
Establish a Global Nonconformance (NC) process to ensure consistency in compliance in areas of investigation, effectiveness, timeliness, quality and thoroughness of content. Collaborate with process owners and stakeholders in corporate, division and site to ensure the program is compliant, executable, and meets user needs.
Lead the rollout of quality system performance metrics to be used at all levels of the organization (site, division and corporate), collaborating with process owners and key stakeholders in corporate, division and site. Ensure metrics are appropriately cascaded through Management Reviews.
Evaluate new regulations, guidelines and industry standards and their impact on quality system processes; plan and effectively implement plans across the business to maintain compliance.
Ensure compliance of all process and digital improvements with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, EU MDR and JPAL.
Interact and coordinate activities with other departments, external vendors, and customers. Influences and collaborates across stakeholder groups in the areas of process / system improvements, identify and implement opportunities.
Drive quality culture improvements and foster collaboration to ensure functional teams work harmoniously and secure the synergy and strengths across the global teams.
Integrate/participate in the overall quality/operation leadership community by sharing and seeking best practices and methodologies in CAPA, root cause investigation and continuous improvement and finding new ways to help drive for maximizing performance.
Provides strategic direction and communication of the company’s goals, directives, and policies to employees, creating a clear vision and positive, team-oriented environment resulting in the achievement of the company’s goals and increased profitability.
Provides leadership and influence among multiple departments and teams to ensure digital transformation initiatives are successfully executed.
Demonstrates technical leadership as an inter-departmental resource coaching and teaching other Integra Leaders across all functions and geographies.
Participate in process mapping with key senior leaders to ensure process and system requirements align.
Develop metrics for measuring project or program success
Lead system implementations, including managing global capital, project, and expense budgets.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and experience required for this position.
Bachelor’s Degree in Engineering, or Sciences or relevant Technical Field.
Minimum 12 years of experience in quality, manufacturing, or engineering
Strong experience leading deployment of enterprise quality management solutions
Experience in FDA controlled environment.
Strong collaboration skills and experience working in a matrix environment.
Ability to interface with technical and non-technical personnel.
Knowledge of current Good Manufacturing Practices (cGMP), FDA, ISO, MDSAP, EU MDR and other applicable standards and regulations.
This position could require up to 30-50% travel.
TOOLS AND EQUIPMENT USED
Power BI, mini-tab, Visio, and other process improvement tools.
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
ADVERSE WORKING CONDITIONS
Some of the responsibilities take place in a laboratory environment. This can require frequent sitting, walking, standing, occasional climbing, stooping, kneeling, and crouching.
The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.
The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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