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Form of workJob Description
Responsibilities:
- Provides oversight for the maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Provides expertise and guidance in complying with policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups through all stages of the audits.
- Prepares reports and/or necessary documentation (e.g., Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
- Coordinates legal requests in support of government investigations or litigations.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
- Responsible for planning, organizing, and editing a variety of RFAIs associated with software, hardware, labeling, post-market vigilance and technical documentation. Coordinate interactions with worldwide competent authorities, notified bodies and international government authorities.
- Drive Quality Management System (QMS) & product continuous improvement through CAPA management. Elevate issues to management as appropriate.
- Coach new CAPA owners through processes and best practice.
- Develop and maintain Compliance policies supporting the Risk Management program.
- Provide expertise and guidance in interpreting governmental risk regulations, agency guidelines and internal policies to assure compliance.
- Lead process improvement projects and assessment of quality plans.
- Support Management during external/internal inspections and participate in the management of external/internal inspections.
- Assist with external/internal audit preparation and responses to external / internal audit observations.
- Maintain working knowledge of domestic and international medical device regulations and guidance documents and their impact on client's operations.
- CAPA Management & Root Cause Analysis Tools
- Technical writing skillset experience writing and reviewing QMS related documentation for ISO 13485 and EU MDR compliance
- Product Service Quality experience preferred
Requirements:
- Bachelor's Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality OR Master's Degree Engineering, Science or technical field with 3+ years of work experience in Engineering and/or Quality.
- Expertise in CAPA compliance & investigation techniques.
- Auditing experience to 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR, the Medical Device Directive and MDSAP.
- Training in Risk Management, ISO 14971:2012, hazard analysis, and Design FMEA.
- Master's degree in Engineering, Program Management, or Compliance.
- Lead Auditor Certification to ISO 13485:2016.
- ASQ CQE, CQA, CSQE and/or CRE certification.
- Familiar with statistical software tools (Minitab, Stat Graphics, Statistica).
- Familiar with IEC 60601 and product specific industry standards.
- Excellent interpersonal and influence skills including efficient collaboration, effective negotiation, and creative problem solving.
- Strong technical experience in complex technology development programs including ability to understand technical information, discuss/decide on a wide array of engineering disciplines and technical/logistical issues.
