Quality Engineering Program Manager, Post Market
Medtronic
Vice President, Global Quality and Regulatory Compliance
NAMSA
full-time
Posted on:
Origin: • 🇺🇸 United States • California, Ohio
Visit company websiteSalary
💰 $171,500 - $200,000 per year
Job Level
Lead
About the role
- Sets the strategic philosophy and direction for NAMSA’s global quality and regulatory compliance systems applicable to all functions and entities. Owns the quality direction including the research, monitoring and communication of current and changing regulations including applicable laws and guidelines.(e.g., US and ex-US GxPs, ISO requirements). Develops and maintains external relationships with key opinion leaders, medical directors and regulatory officials. Designs and implements systems and controls to ensure consistency and compliance with applicable regulatory requirements, across the global NAMSA network. Selects, trains, and supervises staff to perform quality engineering, quality assurance, quality systems and quality/regulatory compliance functions consistent with strategic plans for ongoing implementation of the NAMSA Quality Policy. Oversees the Corporate Quality System ensuring compliance with all national and international standards and regulations, including but not limited to US FDA, CFDA and applicable ISO standards for the Company. Develops and directs the internal quality system support functions for NAMSA, including Document Control, Archives/Records, Training, CAPA, Complaints, Management Review, Business Software Validations, Internal/External compliance Audits, Supplier Approval and Supplier Audits, Quality Engineering, and GxP Quality Data Audit/Review/Approval. Works cooperatively with NAMSA Leaders to implement programs to improve overall quality and increase regulatory compliance. Assures test validation and audits accurately assesses ongoing performance and detects quality problems. Promptly notify management of significant quality system or technical problems. Directs and accomplishes financial objectives for the Quality organization by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions; effective utilization of resources, equipment (engineering) and space. Acts as the primary interface with the US FDA and other regulatory authorities globally for compliance inspections. Develops and maintains a three-year staffing and space requirement plan. Advises and assists clients regarding quality and regulatory concerns.
Requirements
- Requires a Bachelor’s degree in life sciences, pharmacy, engineering or a related field Requires minimum 15 years in Quality Assurance and Regulatory Affairs with at least 5 years in a senior leadership role within the medical device, biotech or pharmaceutical industry Deep knowledge of global regulatory requirements Proven ability to lead cross-functional teams, influence stakeholders and drive strategic initiatives Strong analytical, problem-solving, and communication skills, adept at managing complexity in a global environment P&L experience required Fluency in English and local language, if different, required. Maintains professional competency in Quality Assurance and the biomedical industry in general. Must have familiarity with a broad base of scientific applications sufficient to support understanding and sound risk assessments of NAMSA’s products and processes.
