VP, Quality & Regulatory Affairs

Overview:

We offer a broad array of scanning system configurations that leverage low-, medium-, and high-energy X-ray technology—or multiple X-ray technologies—to address each customer’s unique security application requirements. Our commitment to excellence in imaging performance, innovative design, and uncompromising quality ensures our solutions consistently deliver best-in-class imaging, high reliability, and operator satisfaction, to help customers find threats and contraband with ease and confidence.

Reporting to the President, Rapiscan Detection, the Vice President of Quality & Regulatory affairs (QA/RA) will play a pivotal role in ensureing the highest standards of quality and compliance across Rapiscan's global operations. This senior leadership position demands an analytical thinker with a strong backgroun in quality management, process improvement, and regulatory compliance within a complex manufacturing industry that also includes an extensive after-sales service component.

This enterprise-wide position will be based in the Boston area; or other Rapiscan division offices if applicable.

Responsibilities:

Quality Management Leadership:

• Develop and implement a comprehensive quality management strategy aligned with organizational goals and industry best practices.
• Establish and maintain a culture of compliance and continuous improvement processes throughout the organization.
• Improve performance with a balanced scorecard of KPIs that drives action and produces sustainable results.
• Act as the process owner for embedding quality into Producibility and New Product Introduction (NPI) for products and services, from design for manufacturability through delivery of after-sales service.
• Ensure compliance with Configuration Management rules for complex product lines.

Regulatory Compliance:

• Stay abreast of all relevant regulations and standards and ensure the company's compliance with applicable requirements (electrical safety, radiation safety, CE, RoHS, EHS, etc.).
• Drive the implementation and continuous improvement of environmental policies and practices to meet evolving regulatory and organizational standards.
• Serve as the executive sponsor of the EHS committee for the Security division, ensuring effective communication and collaboration across departments to promote a culture of safety and environmental stewardship.
• Manage and oversee all safety programs, ensuring compliance with safety regulations and fostering a safe working environment for all employees.
• Collaborate with ISO certification agencies to maintain and enhance required certifications.

Process Optimization:

• Identify opportunities for process optimization and efficiency enhancements in key organizational processes.
• Establish systems and processes for tracking and acting upon cost of poor-quality drivers.
• Lead cross-functional teams to implement improvements to drive operational excellence and customer satisfaction.
• Partner with engineering and key stakeholders to drive quality into the design process to ensure defect-free products throughout their entire lifecycle.

Supplier Quality Management:

• Oversee the development and maintenance of robust supplier quality management programs.
• Collaborate with procurement and supply chain teams to ensure the quality of incoming materials and components, and leverage supplier input into compliance with REACH, PFAS reduction, sustainability, and other key initiatives.

Risk Management:

• Support the company’s enterprise risk management program by maintaining a comprehensive risk register and leading divisional mitigation strategies for quality and regulatory related risks in products and services.

Team Leadership and Development:

• Attract, lead, mentor, and develop a high-performing QA/RA team.
• Foster a culture of accountability, teamwork, and professional growth within the extended quality department.

Critical Success Factors

The following critical success factors represent those most critical in year one to ensure success:

• Establish strong, trust-based working relationships with the leadership team, peers, and their own team.
• Develop and implement a globally integrated Quality Management System (QMS).
• Transform the impact of the QA/RA organization by proactively diagnosing and effectively addressing quality issues and challenges facing the company.
• Evolve the Quality leadership team to support the company’s plan and needs going forward.
• Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork
• Demonstrate behavior consistent with the company’s Code of Ethics and Conduct
• It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem
• Duties may be modified or assigned at any time to meet the needs of the business.

Qualifications:

• A bachelor’s degree in engineering, business, or another relevant area required. Master’s degree preferred.
• Minimum of 10 years of progressive experience in QA/RA functions in a complex manufacturing industry with significant regulatory exposure required.
• 5+ years of professional experience in a managerial role required.
• Demonstrated experience managing QA/RA for globally dispersed multinational organizations.
• In-depth knowledge of quality standards, product regulations, and certification processes such as AS9100, ISO 9001, TSA, ECAC, EASA, etc.
• Proven experience in leading and driving continuous improvement initiatives, using quality tools and techniques such as Six Sigma, 8D, root cause analysis, etc. AS9145 APQP/PAPP and Lean certification highly preferred.
• Strong analytical and problem-solving skills, with a data-driven approach to decision-making.
• Excellent communication and people skills, with the ability to build strong relationships with internal and external stakeholders.
• Demonstrated ability to collaborate with cross-functional teams and communicate technical information to non-technical stakeholders.
• Excellent leadership and team management skills, with a record of motivating and developing high-performing teams.

• Achieves results: Manages high-performing teams; is accountable and results-driven; has a bias for action; holds themselves and others accountable; delivers on time with high quality.
• Business acumen: Provides leadership and makes business decisions that drive positive bottom-line performance; understands the business, critical success factors, market tactics, and strategies; utilizes business understanding to plan and prioritize; possesses strong critical thinking capabilities and translates strategy into aligned business actions.
• People leadership: Develops, engages, and inspires people; possesses self-awareness, authenticity, integrity, and humility; demonstrates courage in communication and decision making; delivers clear and respectful feedback; creates psychological safety in teams; enables collaborative problem-solving.
• Organizational agility: Achieves results in a matrix organization; possesses interpersonal intelligence and skills; collaborates up, down, and across the organization to achieve results; uses informal influence and persuasion to drive resources to achieve results.
• Innovation and creativity: Possesses a growth mindset, learning agility, and openness to innovative ideas; actively listens and probes; respects differing thoughts/opinions; facilitates brainstorming and creative processes; demonstrates systems thinking.

Please review our benefits here: Life at OSI

NOTICE TO THIRD PARTY AGENCIES

Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI.

Equal Opportunity Employer - Disability and Veterans

EEO is the Law

Poster Link: https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf

OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.