Chuyên gia chất lượng sản phẩm - Product Quality Expert

JOB SUMMARY
This quality professional will lead all quality-related teams and activities at specific site(s) to drive product quality improvement efforts, act as core member of site leadership team, support and drive site-level projects and efficiencies, and ensure on-going conformance to established applicable standards, regulations and agency guidelines.

ESSENTIAL DUTIES
Drives Improvements to Product Quality:
• Understands customer issues and works to resolve problems with product, procedures and policies, driving significant change to process or system where necessary to resolve these issues.
• Interface with site and global teams to support product complaint investigations and actions, NCs or CAPAs to ensure product conformity as well as support global changes to drive down complaints
• Ensure adequate root-cause investigation and resolution of issues to avoid repeat or inadequate resolution of product quality issues

Facilitation and Relations:
• Develops/maintains constructive relationships with customers, operations, and other business/regional/functional entities served and ensure such relationships exist throughout the organization.
• Simplify problems and develop solutions that eliminate issues and improve relationships across all functions and processes in Terumo BCT.
• Facilitates the sharing of best practices across the company.
• Works with internal and/or external resources to resolve problems of exceptional complexity and sensitivity. May be primary representative of operations or quality group on projects or management teams.
• Works with global and external resources to manage all areas of responsibilities including Operations, R&D, etc.

QMS Compliance:
• Demonstrates knowledge and skills of QMS/cGMP requirements including medical device and combination products.
• Implements QMS to support certification by regulatory bodies.
• Develops and reports and improves on metrics related to QMS.
• Responsibilities include influencing and driving teams in the areas of process improvements, trend monitoring and correlating leading quality metrics, problem solving approaches, and data analysis. Leads root cause analysis of complex systems issues.
• Evaluate changes to products ensuring that the implications of changes are fully understood.
• Leads Management Review for factory that drives active cross-functional involvement and continuous improvement.
• Constantly analyze changing business and customer needs and propose organizational or systems changes to address these needs. Recommends changes to other areas that will improve overall effectiveness.

Process and Systems:
• Responsibilities include factory complaint investigation processes, internal audit processes, and CAPA processes. Works with manufacturing, engineering, and other functional groups on regulatory compliance issues. Develops or participates in the development of solutions to problems of moderate to high complexity. Interprets, executes and recommends modifications to operating policies where appropriate.
• Serves as Management Representative for FDA responsibilities and holds plant manager accountable for role as Management Respresentive with Executive Responsibility.

People Management and Team Development:
• Leads a culture that reflects Terumo Core Values and quality principles. Accountable for continuous development of associates toward expectations
• Ensures effective formal training and development of professional skills and behaviors for associates
• Promotes associates development through participation on cross-functional teams.
• Directs the development and management of budget for areas of responsibility.
• Recruits, selects, trains, appraise performance, and administer salaries of reporting employees; determines assignments and changes employees’ status in accordance with Terumo BCT policy.

Business Processes:
• Ensures that activities are managed in accordance with Terumo BCT Code of Conduct and appropriate business controls.
• Understands business process issues and priorities, and manages resources effectively to resolve problems in the processes, procedures and policies, driving change (systems, tools, training processes, and procedures) where necessary to meet customer and business needs.
• Influences short and long term business goals and operating policy. Exerts influence on corporate objectives and long-range goals in areas related to QMS and compliance.

MINIMUM QUALIFICATION REQUIREMENTS

Education
Bachelors degree in Quality or STEM-related discipline with 10+ years experience, and 5 years management experience, or a Masters Degree in a related discipline.

Knowldege and Experience
• 10 years experience and 5 year management experience, or an equivalent combination of education and experience.
• Demonstrated QMS and audit expertise for Medical Device and Combination products and knowledge of applicable standards (including but not limited to ISO 13485, ISO 14971, MDD, CMDR, FDA Quality System Regulations).
• Extensive knowledge of U.S. and international medical device regulations and standards.
• Requires understanding of quality management requirements and experience in developing quality goals and measures and directing others, including R&D, suppliers, and process engineering.

Skills
• Demonstrated skills in leadership and development of people and teams. Capability to build and maintain effective working relationships across functions and organizations and levels.
• Demonstrated expertise in planning, budgeting, personnel development, and project management directed toward achievement of both short- and long- term business plans and goals.
• Demonstrated knowledge and application of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.
• Demonstrated effectiveness with interpersonal skills and the ability to interface with Senior Management, internally and externally and the ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence.
• Demonstrates a positive, direct, proactive approach to problem solving and impediments, mentors others to understand and model this approach. Constructive and relentless in pursuit of solutions. Motivates others to do the same.
• Ability and success to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis and other analytical techniques.
• Thorough understanding of measures of customer satisfaction and experience in their implementation as a tool for continuous improvement.
• Cultural and situational flexibility and adaptability is essential.