Quickie Wheelchairs - Manual and Power · 3 days ago
DIRECTOR OF QUALITY ASSURANCE & REGULATORY AFFAIRS, NA
Nashville - Nashville, TN
Full-time
Onsite
Director/Executive
10+ years expQuickie Wheelchairs is a company focused on providing manual and power wheelchairs. They are seeking a Director of Quality Assurance & Regulatory Affairs who will develop, implement, and maintain a comprehensive QA/RA system while ensuring compliance with regulatory requirements and overseeing the Nashville site's Quality Department.
Medical Device
Responsibilities
Responsible for the implementation and management/oversight of the quality assurance and quality improvement programs. Ensures that processes and standards comply with all relevant quality standards and regulations; conducts continuous improvement reviews/audits with regards to all relevant policies/procedures and implements corrective action as necessary
Manages, coordinates, and administers all functions of the QA/RA function to achieve company compliance and objectives and demonstrate continuous improvement. Provides constructive and relentless guidance in finding solutions for resolving quality concerns and driving improved efficiencies and on-going continuous improvement. Ensures Quality input into and the monitoring of the Sunrise Product Development Process (PDP) with regard to quality and regulatory compliance
Develops and leads a quality and regulatory staff with the skills and abilities to ensure quality products and regulatory compliance for North America. As required, hires, terminates, evaluates and disciplines employees in accordance with current personnel policies, including performance management and performance improvement plans. Regularly leads and monitors employees’ performance to assure that departmental goals and objectives are met. Ensures that staff is adequately trained and responsive to end user needs and complies with all regulatory/accreditation requirements
Creates, evaluates and completes domestic and/or international quality and regulatory tasks related to submissions, technical file compilation, and strategy to drive market growth worldwide
Collaborate cross-functionally on new product development and strategic initiatives to lead the quality and regulatory activities
Oversees Complaints investigation, MDRs, Corrective and Preventive Action (CAPA), HHE/HARM, Supplier Development/Quality and other related processes, including investigations, resolving quality concerns and issues, maintaining all required documentation and track the progress through the system for timeliness and completeness
Works with Product Management and R&D and Operations to define and improve product specifications and develop vendor specifications and standards to provide customers with the safest and best quality performing product possible
Manage, and establish / maintain compliance with FDA And Health Canada QSRs and other global regulation as applicable. This includes, but is not limited to, timely registration of establishments and listing of devices for all facilities and outsource partners, development and submission of regulatory requirements for product projects, submission of premarket notifications in accordance with FDA and foreign regulatory body requirements, license renewals, initial and annual product reports, etc
As the organization’s official contact/liaison for all regulatory matters, establish and maintain positive relationships with government agencies and other regulatory authorities and represent the organization in matters before such agencies and authorities so that the organization’s goals and objectives are advanced. This includes the management of approved field corrections/product removal activities, filing of MDRs, maintenance of Regulatory Affairs files and regulatory correspondence and all related activities
Represents the business during any inspection/audit processes, internal or external. Implements appropriate activities to ensure regulatory compliance and adherence to the quality system. Serves as the official correspondent to the FDA, Health Canada, ISO, and other global regulatory/accrediting bodies. Monitors, interprets and communicates federal regulation and external changes in the regulatory environment to ensure continued compliance of the quality system in all facilities. In charge of continuously improving the quality management system while being compliant with the medical device regulations
Communicates with all functional groups to ensure awareness of regulatory and quality requirements. Provides and/or coordinates company-wide quality and regulatory training. Provides monthly updates to senior leadership and gains alignment on recommended changes
Aids in liability claim investigation and document collection
Site Quality Management: Manage the Quality team and processes for the Sunrise Medical Nashville manufacturing facility and guide/mentor the Quality Management of other Sunrise Medical manufacturing and distribution sites in North America to continuously improve the quality management system according to 21 CFR 820, ISO 13485, ISO 9001, ISO 14001 and EN 16247-1 and maintaining compliance with all applicable medical device regulations
Quality Statistical Analysis and Reporting: Monitors the quality performance for products both internally (First Pass Yield, rejects, etc.) and externally (DPMO, warranty, complaints, etc.). Leads the DPMO calculation and monitoring for North America and collaborates with international QA/RA colleagues for monitoring and reporting for global products
Provide communication link between operations and engineering to assure proper product development and specifications. Review quality problems with appropriate personnel and direct action required for correcting defects. Work with engineering to develop engineering process validation, product and component test methods, inspection guidelines and quality system procedures
Manage sampling inspection, and testing of received parts, components, and materials to determine conformance to standards, also work with suppliers on quality improvement initiatives
Manage applicable internal audit requirements and process validation requirements supported by data analysis and corrective action reporting to establish consistent adherence to quality systems and support troubleshooting by the plant
Establish and lead a quality staff with skills and abilities to become a true service organization to support the plant in training and technical troubleshooting to achieve plant and company goals
Participates on Build-4-Me Product Development and Manufacturing team to assure that all quality and regulatory issues are addressed for customer requested modification(s)
Establishes Product Quality and Inspection Plans to manage in-process product evaluation points, levels and criteria
Provide guidance and support for QA/RA associates within the Ride Designs and Nuprodx organizations, to support the harmonization and integration of Ride Designs and Nuprodx into the Sunrise Medical organization, ensuring that they achieve compliance to appropriate regulatory requirements
Other duties and projects as required and assigned by Executive leadership
Qualification
Required
Bachelor's degree in Engineering or Technical field from four-year college or university with minimum of 10 years work experience that includes hands-on experience in a manufacturing environment; 5 years minimum in a quality or reliability leadership role that includes experience managing/ supervising quality technicians and engineers
Experience working in a disciplined, regulated industry/medical device environment with quality systems associated with development, manufacture and support of medical devices
Proven leadership in formulating and implementing strategies to ensure product quality and compliance with US and international regulations
Understanding of current inspectional practices of FDA, Health Canada, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessment or inspection
Ability to apply current inspectional techniques to project documentation during the product lifecycle and prior to FDA, Health Canada, or other regulatory inspections to ensure compliance
FMEA/Risk Management – Use dFMEA/ pFMEA/uFMEA (or similar tools) to continuously evaluate potential product risks and reduce those risks through design and process improvements. Ensure compliance of the product risk management documentation according to ISO 14971
Ability to work professionally with highly sensitive information and maintain confidentiality
Demonstrated effective communication skills including writing and presentation skills
A perfectionist with attention to detail - a hands-on “fixer” who continuously strives for excellence. The ability to inspire others to adopt this mentality of prioritizing quality and compliance above all else. Willingness to be directly involved in all tactical and administrative aspects of the position
High energy leader with the ability to manage multiple and varied tasks with enthusiasm; can prioritize workload and constructively interact and negotiate with a range of personalities and many levels of the organization and external entities; achievement oriented and customer focused
Flexibility with respect to work assignments, new learning and travel
Fluent in Microsoft Office applications --- PowerPoint, Word, Excel --- and working knowledge of internet (Microsoft explorer) functions
Experience in implementation and use of SPC in quality controls
Ability to work extended hours and weekends as needed
Ability to travel domestically and internationally as needed is required
Excellent organizational ability, including ability to manage deliverables and timeline for execution to achieve project goals
Ability to interact professionally and sensitively with customers and end users as well as legal staff is required
Good stress management including the ability to function effectively when under pressure and maintain self-control in the face of hostility or provocation
Company
Quickie Wheelchairs - Manual and Power
For over 25 years, Quickie has listened, researched, tested and delivered.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase