The Quality Assurance Manager is responsible for leading the affairs of Quality Assurance for Nihon Kohden America. This role is responsible for maintaining the quality management system (QMS) infrastructure and ensuring it is compliant, simple, effective, efficient, and defensible.
This position is responsible for providing oversight for all the elements of the QMS including design control, risk management, complaint handling, CAPA, training, design control, document control, and production and process activities. Additional responsibilities include establishing and sustaining corporate quality goals, managing and improving all aspects of the quality system, managing and conducting internal or external audits as needed. Strong leadership and team building skills are required to manage the Quality Assurance team to ensure quality initiatives are met. Proven experience with medical device, measurement and management techniques, analysis of product and process failures, performing root cause analysis, use of data driven decision making and implementing corrective and preventative actions are required.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
Directs and provides expert knowledge in the day-to-day function of Quality Assurance
Maintains compliance program to ensure compliance with regulatory requirements, international standards, company policies and procedures, acts as the Management Representative appointed by Management with Executive Responsibility
Directs inspections and audits (internal and external) and related compliance activities; maintains productive working relationships with external regulatory bodies. Ensures effective resolution of corrective actions to resolve any deficiencies identified during audits
Leads Supplier Quality Initiatives
Maintains programs that ensures the verification and monitoring of the effectiveness of the QMS and its compliance to applicable regulations and standards
Manage resolution of internal and external audit
Responsible for the QMS functions related to management review, design control, risk management, CAPA, complaint handling, non-conformance, quality planning and objectives, document management, change control, records management and other areas of responsibility
Leads Post-Market Quality Activities, including vigilance reporting/MDRs
Effectively manages complaint and CAPA systems, ensuring timely results, accurate and consistent identification, and compliant documentation and reporting of MDRs or other actions
Reviews and approves master match record and executed batch record and quality issue resolution, and batch disposition
Provides training related to regulatory compliance, QMS, or other related subjects as needed
Provides QA support for marketing, service, documentation, product development, supplier management or other areas as needed
Lead and/or support quality initiatives to continuously improve the overall quality of the commercially released products
Perform and assign responsibilities within QA to ensure company objectives are achieved in a timely manner.
Support the NKA Quality Policy and Quality System.
Adheres to all company policies, procedures and business ethics codes
Other duties as assigned
Solid knowledge of quality systems, ISO standards, FDA regulations and expectations
Demonstrated ability to successfully interact with regulatory agencies at inspections (prior experiencing leading inspections is required)
Experience interacting directly with the FDA and other regulators during inspections, audits and/or field actions is required
International regulatory experience preferred
Project management experience desirable
Strong communication skills and ability to work closely with people at all levels of the organization
Good conceptual, analytical, problem solving, and organizational skills, including demonstrated prior accomplishments
Outstanding leadership capabilities to build, motivate and manage a strong quality organization
Ability to think strategically and bring a high level of inventiveness to the organization
Flexible mindset and ability to adapt to a rapidly changing environment
Well-organized and accustomed to maintaining excellent records
Ability to travel (domestic and international) as required, approximately 10%
Education/Certification: Bachelors Degree required in engineering, life sciences, or similar technical field; MBA or MS preferred
Knowledge of process-based risk management system
Knowledge of Design Assurance and product-based risk management
Understanding of document control and learning management systems
Understanding of GMP, MDD, FDA 21 CFR 820, ISO 13485, PMDA-JPAL, Canadian Medical Device Requirements
Quality Systems Software: Configuration Management / Learning Management Systems
Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines and policy statements.
Candidate must be proficient with office computer systems (Microsoft Office suite).
Effective presentation and interpersonal skills
Excellent verbal/written communication skills
Self-starter and ability to learn
Strong attention to detail and accuracy
Ability organize records, interpret regulations and implement procedures
Project Management experience
TRAVEL: Ability to travel (domestic and international) as required, approximately 10%
SPEAKING: Able to speak and present information in front of groups
PHYSICAL: Able to carry up to 25 pounds