Vice President, Quality Operations CSS

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY DESCRIPTION

The VP , Quality Operations is a key member of the Quality L eadership T eam (QLT) and the Codman Specialty Surgical ( CSS ) Divisional Leadership Team with primary responsibility to ensure the delivery of high-quality products and services to our customers . This position has direct responsibility for quality across our CSS division with nine manufacturing sites and a network of stakeholders focusing on compliance, quality, safety, and efficiency . This individual will build strong partnerships with all internal functions, ensuring demand is met as well as cGMP compliance and will work internally across the organization to provide the passion, vision and results-oriented leadership required to build a world-class quality organization . T his role is crucial for ensuring the development, manufacture, and distribution of medical devices in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical Affairs Law, and other applicable regulatory agencies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily as follows:

• Create and implement best practice quality vision, strategy, policies, processes, and procedures to aid and improve business performance . Lead and d rive operational efficiencies and compliance across all Integra CSS manufacturing sites . Provide overall quality management oversight and leadership for the CSS division such as monthly management reviews, site compliance, non-conformances and CAPA, product holds, audits, product release and inspection, complaint investigation, facilities and equipment controls, and more . Partner with the Quality Leadership Team to ensure the delivery of high-quality products and services to our customers .

• Ensure that Quality meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives . Provide strategic direction and communication of quality performance across the CSS division, creating a clear vision and integration with overall business objectives . Develop and monitor key performance indicators (KPIs) to assess the performance of product quality and the quality management system . Highlighting trends, risks, and opportunities for improvement.

• Proactively drive continuous improvement activities to ensure problems are prevented and issues resolved efficiently and economically . Foster a culture of quality and continuous improvement within the organization. Promote the use of lean and Six Sigma methodologies to enhance quality and operational efficiency. Stay abreast of industry trends and advancements in quality management practices . Monitor and partner with the Quality Leadership Team to ensure that Integras Quality Systems continue to meet emerging industry trends.

• Proactively work to ensure the organization has the right structure and competencies to meet the current and future needs of the business . C reate and build confidence by establishing the quality function as an informed, capable, knowledgeable, and accessible resource to staff, management, and stakeholders.

• Build a high - performance quality culture and team, empowering and holding direct reports and cross-functional teams accountable for product quality . Leads with authority and influences globally across ten manufacturing facilities and cross functional stakeholders including but not limited to quality, commercial, product development, process technology, operations, supply chain, procurement, regulatory affairs, financ e, and human resources .

• Communicate effectively with internal and external parties regarding quality initiatives . P rovide regular status updates on product quality to key stakeholders including divisional management, executive leadership and board of directors .

• Support interactions with regulatory bodies and ensure compliance with all applicable quality and safety standards . Guide the activities required of the quality organization to ensure compliance with all appropriate regulations and standards, including FDA Part 820 , ISO 13485, CMDR, MDR , MDSAP, and JPAL. Ensures compliance and readiness globally in collaboration with the QMS.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelor's degree is required , i n engineering , science or closely related technical d iscipline is preferred. A Ma s ter s degree preferred

• 18 + years of experience leading a team (direct reports or projects) or equivalent education and years of management experience

• Experience in highly regulated industries required , medical device and/ or pharmaceutical preferred , including material remediation experience

• Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.

• Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), Japanese Pharmaceutical Affairs Law, and other national and international regulations and standards.

• Experience with direct contact with FDA and EU Notified Bodies.

• Knowledge of process design and implementation, change control, auditing, and document management systems required , g eneral knowledge of statistical analysis preferred.

• Demonstrated organizational, management and communication skills. Proven track record of cross-functional collaboration across teams and change management skills.

• Ability to travel up to 50 % if needed based on site needs . R egular on-site presence in US facilities including Massachusetts , Ohio, Utah, California, Puerto Rico ; European facilities including Switzerland, France, Germany and Ireland ; and a facility in China .

INTEGRA LEADERSHIP CAPABILITIES
As a senior leadership position in the company, the role is expected to demonstrate on all Integra Leadership Capabilities.

• Enterprise Mindset: Leaders with this capability make decisions, set priorities, and share resources based on what will benefit Integra as a whole.

• Thought Leadership: Leaders with this capability build personal credibility and utilize business acumen and customer mindset to influence the innovation and growth of the business.

• Drive Performance: Leaders with this capability drive performance and accountability through others and self.

• Enable Talent: Leaders with this capability strive toengage, support, and develop self and others, optimizing the success of individuals and teams.

TOOLS AND EQUIPMENT USED

Ability to utilize a computer, telephone, smart phone as well as other general office equipment. Strong computer skills are required . Power BI, mini-tab, Visio, and other process improvement tools.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order 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.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility . This can require frequent sitting, walking, standing, occasional climbing, stooping, kneeling, and crouching . Must be capable of using a keyboard for computer purposes . The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds. Must be able to independently travel via car or airplane to domestic and international locations as needed.

ADVERSE WORKING CONDITIONS

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and res ponsibilities of this position.

Some of the responsibilities take place in a laboratory environment . This position could require up to 50% travel.

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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