Director Quality Assurance Governance - Remote

Job Description

Responsible for communications within the Quality Design Assurance organization. Develop and deploy quality leadership and technical development programs through cross-functional partnership. Plan and direct the execution of complex Quality projects across the Quality Design Assurance Team relating to process standardization and/or improvement, integration and regulatory compliance. Identify improvement opportunities and provide expertise in various process improvement methodologies and problem-solving approaches. Implement and maintain process improvement methodologies and tools. Demonstrate capability in establishing process stability in a challenging and complex environment.

Job Duties

* Research, develop, work collaboratively and implement communication strategies and initiatives that support the Product Quality organization.

* Lead communications, public relations and media relations programs and announcements.

* Identify, develop and evaluate external Quality and Compliance trends and hot topics and convey them to the organization through a variety of media such as newsletters, bulletins, videos.

* Engage with corporate communication functions globally on proactive and reactive issues, including sharing customer stories, employee experience through interviews, focus groups, surveys and analysis of data.

* Design programs to help the business identify and nurture high performers, and develop future technical experts, managers and leaders.

* Build out a comprehensive set of multi-modal training opportunities to provide ongoing training and development opportunities for employees and managers in the Quality organization.

* Work closely with HR and other business leaders to develop and implement leadership development programs.

* Establish and maintain Quality recognition programs that align with company objectives and promote a Quality and customer-centric culture.

* Lead or support quality and compliance projects as requested, and perform other assigned duties as needed.

* Establish and maintain continuous improvement program and portfolio of projects and lead highly complex projects requiring facilitation and collaboration across organizational functions.

* Develop and deploy training programs in Six Sigma, Lean, Root Cause Analysis (RCA), Transactional Process Improvement (TPI) and other problem-solving methodologies and tools.

* Identify focus areas for improvement/streamlining, development and execution of operational initiatives, monitoring of operational goals and leadership objectives. Proactively identify issues with critical importance, assess areas of risk, provide advice, and propose solutions. Gather, analyze data, and effectively respond to new, complex or problematic situations; create solutions that drive value for the company and customers.

* Facilitate Kaizen events to ensure that product design, manufacturing and service/repair processes continuously improve.

* Model and teach scientific problem-solving approaches to group and business partners.

* Provide resource to execute on complex Quality and Regulatory projects across the Global Product Quality Team.

* Actively collaborate with cross-functional, internal and external stakeholders to harmonize best practices to improve product quality.

* Develop and manage a technical team including direct and external consultants to support and improve product quality through design and manufacturing. Ensure the required competencies, talent management and development of people within their organization through a coordinated partnership at both the Site and Global levels.

* Set clear performance goals and develop team members to support the business and individual professional growth. Provide direction, guidance and coaching as needed. Develop a team culture of continuous improvement and teamwork that strives to improve in quality, safety, delivery and cost.

* Develop and manage budgets for the project including resource loading, external expenses and capital requirements.

* Lead or support quality and compliance projects as requested, and perform other assigned duties as needed

Job Requirements

REQUIRED QUALIFICATIONS:

* A minimum of a 4-year college degree (Bachelor’s Degree) or equivalent in a technical or science-related field is required

* Minimum of 10 years of experience in technical or Quality experience in the medical device field or any other regulatory controlled industry.

* Previous experience leading a medium to large organization and influencing senior level management and key stakeholders with demonstrated leadership capabilities and leverage network and partnership for effective collaboration of critical quality initiatives.

* In this Global role, the individual will be expected to schedule meetings that work for multiple time zones and up to 20% travel should be expected, sometimes in short notice.

PREFERRED QUALIFICATIONS:

* Lean Six Sigma Black Belt Certification is desired.

* Experience working with multi-disciplinary senior leadership members and analyzing, clarifying and translating business requirements into functional and technical specifications is a plus.

* Process improvement methodologies such as Six Sigma, Lean Manufacturing, and 5-Whys analysis.

* Highly advanced organizational and project management skills.

* Proven leadership, teamwork, collaboration and influencing skills; demonstrated initiative and assertiveness; strong computer skills and use of software applications such as MS Windows, MS Office (Word, Excel, PowerPoint, Visio); strong written and oral communication skills, are required.

* The ability to lead and manage remote, matrixed people in teams in both global and regional environments is highly preferred.

* Strong relationship skills with the ability to foster a sense of community with cross-functional stakeholders.