Sr Mgr, International Quality Management Systems

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Description/Job Summary

To manage Medical Device Requirements for Pride Brand products and the Quality Management System as outlined by 2017/745 EU MDR and ensure overall compliance with international regulations 

Responsibilities/Duties

•Responsible for the overall Quality Systems of all Pride Brand products in the European Union (EU)
•Create and conduct corporate-wide training annually regarding the EU regulations
•Act as the lead auditor for internal audits of the Quality Management System for the EU subsidiaries
•Ensure internal and external audit schedules are established and audits are conducted in the EU
•Assist external auditors, where needed
•Oversee and conduct post-market surveillance activities including:
          •Post Market Clinical Follow-Up
          •Vigilance Reporting
          •Trend Requirements
          •Customer Complaints
          •Serious Incidents
          •Field Safety Action Requirements
          •Issuance of Corrective and Preventive Action (CAPA)
•Review annually and revise, when needed, Clinical Evaluations
•Assist in the development of reconstruction of the US FDA 21 CFR Part 820 Quality System Regulation to ISO 13485 Medical Devices, Quality Management Systems
•Conduct and evaluate the justification for risk-based classification and conformity routes
•Assess the EU Medical Device Regulation (MDR) impact on quality management system requirements
•Evaluate EU MDR requirements related to Risk Management, General Safety and Performance Requirements, and Common Specifications
•Establish and oversee the creation and maintenance of Technical Documentation including approvals
•Review daily correspondence, Public Notifications, and Guidance Documents as released by the European governing bodies
•Correspond to the EU governing bodies on all matters regarding field corrections or removals
•Serve as liaison during any EU inspections
•Oversee EU Quality System implementation and ensure compliance with applicable regulatory requirements
•Review all controlled documents prior to release to determine if the change(s) affect the safety or effectiveness of the device and determine if the change requires regulatory action
•Direct the EU Regulatory staff which includes CAPA, Document Control, Deviations, Technical Documents, and Complaint Handling
•Serve as a liaison and/or lead for EU Continuous Improvement Committees
•Ensure compliance and advocate for Pride Mobility Products/Quantum Rehab Equal Opportunity/Affirmative Action placement and utilization goals and hiring benchmarks through non-discriminatory employment practices across your Area of Responsibility (AOR)
•Staff management including documenting and communicating objectives, positively impacting employee morale, motivating team members, conducting performance appraisals, and appropriately addressing individual or group performance issues
•Ensure all safety and security rules are strictly observed and any accidents, incidents or injuries are promptly reported to management
•Attend the Annual C-TPAT Security Training
•Assign, train, and develop staff based on experience and departmental goals
•Develop goals and objectives, and measure outcomes to ensure goals are met
•Focus on continuous improvement, and consistently demonstrate good business judgment
•Develop a "Strong 2nd" for your area of responsibility
•Work effectively with all Pride departments to exceed internal and external expectations
•Pride retains the discretion to modify duties and/or assign other duties as necessary

Required Skills

•Must be a friendly team player, professional, detail-oriented, and honest

Must have the ability to:
•Multi-task, problem-solve, and prioritize in a fast-paced working environment
•Guide, direct, and motivate personnel especially on Quality Management System goals
•Explain complex concepts to non-technical audiences in a respectful and friendly manner
•Travel internationally 25% of the time, for up to 2 weeks at a time


Must have:
•Relentless drive to achieve advancement and continuous improvement
•Intermediate working knowledge of Microsoft Office Word, Excel, and PowerPoint
•Basic working knowledge of Microsoft Office Access
•Excellent web navigation skills
•Excellent presentation, verbal and written communication skills

Required Experience

•At least 5 years of experience with managing Quality Management Systems or Regulatory Systems which may include: International Organization for Standardization (ISO), Food and Drug Administration (FDA), Customs-Trade Partnership Against Terrorism (C-TPAT), American National Standards Institute (ANSI), Rehabilitation Engineering and Assistive Technology Society of North America (RESNA), and/or European Medical Device Requirements (EU MDR)
•At least 2 years of experience with managing at least 3 staff members

Preferred Experience

•At least 1 year of quality work experience in an EU MDR regulated device or pharmaceutical company preferred

Required Education

•Bachelor’s Degree in Business, Engineering, Health/Safety, Humanities, Social Science or a related field
•Certified Lead Auditor Certificate or Certified EU MDR auditor certificate

Preferred Education

•Master’s Degree in a related field preferred
•Certification(s) from the American Society of Quality or other certifying bodies which can include Lead Auditor, Lean, Six Sigma, Process Management, ISO 9001, ISO 13485, ISO 14001 preferred

Details

•This job description is not intended to be all-inclusive
•This is a safety sensitive position
•In exceptional circumstances, some of the physical requirements of this position may be modified or eliminated as a reasonable accommodation for a person with a disability as defined by the Americans with Disabilities Act

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We are an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.