Sr. Director, Global Quality Systems
The Sr. Director of Global Quality Systems provides strategic leadership to support the design, implementation, alignment and functioning of the Global Quality System to support the needs of the global business; ensure alignment with executive leadership strategic plans; and ensure compliance to governmental regulations such as US FDA requirements, ISO13485 and other international standards and requirements as appropriate. This position directs a business-critical function through lower management levels where the scope and complexity of responsibilities require the integration of multiple disciplines and departments (e.g., Engineering, Manufacturing, Operations).
Primary Duties/Responsibilities: (give an estimated percentage of time for each duty)
Directs and leads Global Quality System activities and ensures that processes and procedures are current and compliant with the regulations and standards in which KCI and affiliates operate and sell products.
Identifies processes to be improved and develops and implements new processes and procedures to address gaps
Supports the design, validation, implementation and maintenance of the quality data systems and the IT strategy associated with such systems
Maintains and provides oversight to specific functions within the Global Quality System including, but not limited to:
- Corrective and Preventative Action
- Complaint Handling, including Adverse Event reporting
- Risk Management
- Post Market Surveillance
- Internal and External Audits
- Document Control and Configuration Control
Responsible to ensure compliant and robust processes are maintained throughout the Global Quality System.
Establishes quality goals and requirements by designing, organizing and promoting a quality culture; developing and disseminating standards, metrics, standard operating procedures (SOP) and documents and production records guidelines
Provides guidance and oversight for management controls through the management review process, and establishment of annual strategic objectives.
Provides leadership to assure quality in all functions of the organization
Establishes and builds relationships with internal and external partners to support strategic direction of the business
Performs other duties/responsibilities as assigned by management
Position Scope and Magnitude:
Please list parties interacted with and its effect on organizational operations.
This position is directly related to the welfare of the business and is responsible for items such as the security of proprietary company information and for the performance of products and processes. Error in the performance of these responsibilities would result in a significant financial loss to the company in the form of unnecessary expense, nonconforming product, recalls, law suits, and process and organizational inefficiency. Decisions and recommendations have significant long-term impact on the corporation. The position interacts across a variety of functional areas within the business including research & development, operations, engineering, regulatory affairs, supply chain, information technology, compliance, and executive management. The position supports broad function-wide objectives which are established under the general direction of senior management and guided by approved operating plans.
Please list the amount of annual budget for which this position has direct control or approval authority.
Budget: Approximate annual budget of $3.0 million USD not including capital project investments and professional/consulting expenditures, as required.
Please list any other measures of magnitude (i.e. sales revenue, sales volume, size of portfolio)
BA in Engineering, Science, Life Science .
Advanced Degree in Engineering, Science, Life Science, Business preferred.
7-10 yrs Quality Management and Quality Systems or related functions within a Medical Device environment .
Other Required Skills:
- Demonstrated knowledge and experience in the FDA, or other highly regulated, environment
- Ability to develop departmental budgets
- Ability to travel domestically and internationally
- Demonstrated successful interactions with regulatory agencies and representatives during audits and/or product submissions
- Software and process validation and verification experience
- Experience with standard business applications such as Microsoft Office
- Strong communication and presentation skills
- Strong analytical skills
- Previous background and experience with other related functions, including product development, engineering and manufacturing / operations
- Advanced degree in a technical or business discipline
- Industry certifications in Process Excellence (e.g., Six Sigma Green Belt/Black Belt) and ASQ (e.g., CQM, CQE, CQA)
- Experience with industry-specific business/software applications such as Minitab, Product Lifecycle Management systems, and quality systems applications
Supervisory/Functional Management Requirements:
- Directly supervises approximately 10 employees.
- Indirectly supervises (employees working for your direct reports) approximately 20 employees.
KCI is an Equal Employment Opportunity/Affirmative Action, Federal Contractor employer. All qualified applicants are encouraged to apply and will be considered without regard to race, sex, color, religion, national origin, age, genetic information, disability, protected veteran, or other legal protected status.The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor