Job Category: Quality
QMS Impact Category: Direct Position SummaryReporting to the Senior Director, Global QMS, the Director, Customer Quality position will manage complaint handling activities ensuring that our teams meet quality, safety and compliance standards. This role will maintain, and continually improve a robust Supplier Quality Management System in support of ASP's business strategy and objectives. Responsibilities also include leading a team of individuals through completion of reportability determinations, medical reviews and justifications as well as timely evaluation, investigation and closure of reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards. The manager will also have overall responsibility for ensuring customer complaint investigation processes are compliant, effective, and efficient and that continuous improvement through corrective and preventive action processes are effectively implemented throughout the organization.
Duties and ResponsibilitiesUnder limited supervision, general direction, etc. and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position will:
Establish, lead, maintain and continuously improve all Quality activities associated with suppliers and contract services including finished goods, raw materials, components, manufacturing support services, and product distribution providers.Direct the standardization of Supplier Quality processes that drive Customer Quality efficiencies.Develop policies and requirements for Supplier Quality Management Systems to ensure compliance while minimizing product quality risk in order to expand business portfolio.Implement procedures for effective complaint processing, complaint investigation and supplier performance.Initiate Company Issue Escalation, CAPA, and Customer Response letters as needed.Evaluate Reportability Determination for US Medical Device Reports (MDRs) and Reports Required in Other Regions.Maintain Compliance to Applicable Foreign and Domestic Regulations Governing the Management and Processing of Medical Device Related Complaints including Protected Health Information (PHI) and Patient Privacy Laws.Implement appropriate metrics to track & monitor compliant management lifecycle to include but not limited to regulatory reporting, cycle time aging.Collaborate with the Field Service Engineering, Medical Affairs, manufacturing, and other departments to ensure complaint investigations are complete, thorough, timely and meet regulatory reporting requirements.Find opportunities to continually improve customer quality and supplier performance consistent with the Quality Business Objectives.Collaborate with cross-functional teams to ensure quality considerations are integrated into all stages of the product lifecycle, from development through post-market surveillance.Provide oversight and direction for all quality-related risk management practices in an effort to proactively address potential threats to product quality and provide appropriate solutions that address business needs and are aligned with the Company's core values.Drive continuous improvement metrics and scorecards to support supplier performance management.Continuously assess and refine quality assurance strategies in support of customer and supplier quality, ensuring adaptability and responsiveness to changing organizational and business needs.Be responsible for communicating business related issues or opportunities to next management level.QualificationsEducation: Bachelor's Degree required, preferably in Engineering, Business, Regulatory, or Operations Management.Years of Related Experience: Minimum of 7+ years of business experience is required. Experience in Quality and Regulatory Compliance in Medical Devices.Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations: Ability to engage senior management in identifying critical needs and to ensure effective deployment globally.Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. Employee must be able to effectively prioritize and manage multiple activities and responsibilities.Knowledge of QMS, ISO 13485, EU MDR.Proven track record to work remotely and partner globally required.Ability to communicate clearly and concisely across all levels of the company.Ability to cultivate an effective multi-functional, cross region, cross company team environment required.Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details is required.Extensive knowledge of global quality assurance principles, practices, and methodologies, with a strong emphasis on GMPs, the Fortive Business System and other relevant regulatory standards.Responsibility for Others and Internal InteractionsSenior/Staff Quality EngineersExternal InteractionsPosition requires interactions with External Manufacturers and suppliers. May interact with government agencies and Notified Bodies (i.e., FDA, TUV) as required.
Physical & Work Environment RequirementsPhysical Requirements: The physical demands identified are representative of the physical requirements necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of this job. While performing the responsibilities of this job, the employee may be required to talk and hear.
Work Environment (mark all that apply): Travel on the Job: Up to 30% ? Domestic ? International ?Scheduled Work Hours ?Shift Work ?On Call (Call in for Work) ComplianceAll employees have a duty to comply with applicable laws, regulations, standards, ASP policies and procedures. This job description is intended to convey information essential to understanding the scope of this position and it is not intended to be an exhaustive list of skills, efforts, duties, responsibilities or working conditions associated with the position. Employees are required to follow any other job-related instructions and perform job-related duties as may be reasonably assigned by his/her supervisor. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties of the job.
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