DIRECTOR OF QUALITY ASSURANCE & REGULATORY AFFAIRS, NA - Military veterans preferred

POSITION SUMMARY:

The Director of Quality Assurance & Regulatory Affairs (QA/RA) will develop, implement, and maintain a comprehensive Quality Assurance & Regulatory Affairs system in accordance with regulatory/accrediting requirements and in conjunction with the Sunrise Medical Global QA/RA Group. Responsible for ensuring that Sunrise Medical products meet the requirements and expectations for both our customers and our internal stakeholders. Collaborates with cross-functional departments and global functions to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. Works closely with the Global QA/RA team in post market surveillance activities and global best practices development. The Director of QA/RA will be a highly participative leader, responsible for the hands –on management and direction of Quality Assurance and Regulatory Affairs for North America implementing “best practices”, continuous improvement and corrective/preventive actions as necessary. The Director is responsible for ensuring that processes and initiatives are compliant with all applicable external standards and regulatory requirements and all applicable Sunrise Medical policies, initiatives, and procedures, as well as successfully interacting with and managing Sunrise Medical’s relationships and compliance with approval agencies such as the US FDA, Heath Canada, etc. Serves as the Person with Regulatory Responsibility (PRRC) and Management Representative for Sunrise Medical North America.

The Director is responsible for managing, coordinating, and administering all functions of the Nashville site Quality Department, while serving as a resource to other Nashville functional groups to achieve the objectives of safety, quality, efficiency, productivity, customer service, regulatory compliance, and demonstrating continuous improvement. Responsible for providing direct support and oversight of product and manufacturing engineering activities including manufacturing process capability and supply chain quality management. The Director is responsible for Quality & Regulatory oversight at Ride Designs and Nuprodx, providing guidance and support for QA/RA responsible associates within the Ride Designs and Nuprodx organizations.

PRINCIPAL JOB DUTIES & 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.

REQUIRED SKILLS, KNOWLEDGE AND EXPERIENCE:

• 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.

COMPETENCIES:

• Analytical Thinking – Approaching a problem by using a logical, systematic, sequential approach.
• Attention to Communication – Ensuring that information is passed on to others who should be kept informed.
• Building Collaborative Relationships – Developing and maintaining partnerships with others.
• Decisiveness – Making difficult decisions in a timely manner.
• Developing Others – Delegating responsibility and coaching others to develop their capabilities.
• Diagnostic Information Gathering – Identifying the information needed to clarify a situation, seeking that information from appropriate sources, and using skillful questioning to draw out the information.
• Establishing Focus – Developing and communicating goals in support of the business’s mission.
• Forward Thinking – Anticipating the implications and consequences of situations and taking appropriate action to be prepared for possible contingencies.
• Fostering Teamwork – As a team member, the ability and desire to work cooperatively with others on a team; as a team leader, interest, skill, and success in getting groups to learn to work together cooperatively.
• Influence Skill – Gaining others’ support for ideas, proposals, projects, and solutions.
• Initiative – Identifying what needs to be done and doing it before being asked to or required by the situation.
• Managing Performance – Taking responsibility for one’s own or one’s employees’ performance, by setting clear goals and expectations.
• Personal Credibility – Demonstrated concern that one be perceived as responsible, reliable and trustworthy
• Persuasive Communication – Planning and delivering oral and written communications that are impactful and persuasive with their intended audiences.
• Providing Motivational Support – Enhancing others’ commitment to their work.
• Results Orientation – Focusing on the desired end result of one’s own or one’s unit’s work; setting challenging goals, focusing effort on the goals, and meeting or exceeding them.
• Self Confidence – Faith in one’s own ideas and ability to be successful; taking an independent position in the face of opposition.
• Thoroughness – Ensuring that one’s own and other’s work and information are complete and accurate; careful preparation for meetings and presentations; following up with others to ensure that agreements and commitments have been fulfilled.

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Written Comprehension — The ability to read and understand information and ideas presented in writing.
• Oral Comprehension — The ability to listen to and understand information and ideas presented through spoken words and sentences.
• Oral Expression — The ability to communicate information and ideas in speaking so others will understand.
• Written Expression — The ability to communicate information and ideas in writing so others will understand.
• Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense.
• Problem Sensitivity — The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
• Speech Clarity — The ability to speak clearly so others can understand you.
• Inductive Reasoning — The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
• Information Ordering — The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
• Fluency of Ideas — The ability to come up with a number of ideas about a topic (the number of ideas is important, not their quality, correctness, or creativity).
• Category Flexibility — The ability to generate or use different sets of rules for combining or grouping things in different ways.
• Originality — The ability to come up with unusual or clever ideas about a given topic or situation, or to develop creative ways to solve a problem.
• Selective Attention — The ability to concentrate on a task over a period of time without being distracted.
• Attendance – Regular attendance is required.
• Overtime – Must be able to work overtime, as required.
• Travel – Ability to travel for business purposes.