Quality Compliance Specialist II (Germantown)

Job PurposeThe Quality Compliance Specialist II is responsible for performing thorough investigations of product complaints in accordance with Company policy and external regulatory requirements, as applicable. The position also assists with Quality Management System reviews, supports quality audits, and maintains departmental procedures that drive and ensure compliance with US and International requirements.Essential Duties & ResponsibilitiesComplaint HandlingFacilitates the compliant handling process by receiving, reviewing and entering product complaint information into database.Coordinates and prioritizes complaint investigations to ensure that complaints are processed in a timely manner.Responds to client, regulators or others as necessary within time restrictions.Organizes and facilitates meetings to discuss complaints, prepares meeting minutes, and follows up on action items.Evaluates information obtained during complaint investigation to determine if device failed to meet specifications.Resolves issues or provides clinical/technical explanation to complainant regarding reported event.Ensures proper disposition of returned products for complaint analysis.Regulatory ReportingEvaluates complaint information and determines appropriate regulatory reporting requirements.Prepare and submit reports to FDA and other regulatory agencies within required timeframes.Post-Market SurveillancePrepares and analyzes complaint reports on a bi-weekly, monthly and annual basis.Participates in Post-Market Surveillance (PMS) activities.Support corporate Regulatory Affairs by providing information for submissions and Annual Reports.May perform other duties as assigned by supervisorTraining & DocumentationCreate documentation and train departmental and corporate personnel on the complaint handling, adverse event/vigilance reporting requirements and monitor compliance.Responsible for staying current on international regulations and incorporating any revision or changes needed into SOPs, work instructions, etc.Project ManagementMonitor assigned projects and tasks to ensure compliance with regulatory agencies, protocols, agreements, and applicable corporate compliance requirements. Responsibility may extend to oversight of other individuals/organizations.CollaboratingWorking cooperatively with others to help a team or work group achieve its goals.Continuous ImprovementOriginating action to improve existing conditions and processes; identifying improvement opportunities, generating ideas, and implementing solutions.Managing WorkEffectively managing ones time and resources to ensure that work is completed efficiently.Technical/Professional Knowledge and SkillsHaving achieved a satisfactory level of technical, functional, and/or professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise; leveraging expert knowledge to accomplish results.Working through vision and valuesKeeping the organization's vision and values at the forefront of daily actions.Education/ExperienceBachelor degree with a minimum of 2-year experience, or Associate degree plus 5 years experience in Regulatory, Quality Control, Healthcare or equivalent experience. Knowledge/SkillsKnowledge of FDA regulations 21CFR Part 803 and ISO13485.Knowledge of medical device products and manufacturing processes a plus. Knowledge of FDA, Canadian, European regulations and quality system regulations, helpful.Ability to analyze data, looking for trends & finding ways to summarize and report findings.Ability to prioritize work load to ensure accurate work within strict time frames in regards to investigating, answering & reporting complaints.Ability to multi-task and independently manage workload.Must possess excellent verbal and written communication skills.