Lead Manager, CAPA and Nonconformance Strategies

2 weeks ago

Princeton, New Jersey, United States Integra LifeSciences Full time

Integra LifeSciences - Lead Manager, CAPA and Nonconformance Strategies

Joining our team presents an opportunity to engage in impactful work that drives transformation and influences the future of healthcare. Embracing innovative thinking is at the core of our mission. For us, change signifies opportunity. Daily, over 4,000 professionals are pushing boundaries and making strides to enhance outcomes.

Role Overview:

The Lead Manager, CAPA and Nonconformance Strategies is tasked with formulating and spearheading the execution of Integra's Global Quality Management System Compliance Processes, specifically focusing on CAPA and Nonconformances. Collaborating with leadership in process and Quality Operations, this role aims to foster uniform best practices for CAPA, Nonconformances, Management Review, and Metrics while establishing comprehensive global oversight.

Key Responsibilities:

  • Establish a Corporate CAPA board to tackle company-wide Corrective and Preventive actions, which includes identifying issues, conducting investigations, implementing corrective actions, and verifying their effectiveness.
  • Develop a Global Nonconformance (NC) process to ensure compliance consistency in investigations, effectiveness, timeliness, quality, and thoroughness of documentation. Work alongside process owners and stakeholders across corporate, division, and site levels to ensure the program is compliant and meets user requirements.
  • Lead the implementation of quality system performance metrics applicable at all organizational levels (site, division, and corporate), collaborating with process owners and key stakeholders to ensure metrics are effectively communicated through Management Reviews.
  • Collaborate closely with NC and CAPA owners to ensure adherence to timelines and maintain high-quality documentation.
  • Standardize alert and action thresholds for escalations to senior leadership and relevant stakeholders.
  • Integrate key process indicators of NCs and CAPAs into Quality Management Reviews.
  • Assess new regulations, guidelines, and industry standards to determine their impact on CAPA and NC activities; devise and implement plans across the organization to uphold compliance.
  • Perform additional duties and responsibilities as assigned.

Qualifications:

The following qualifications are representative of the knowledge, skills, and abilities required for this position:

  • Education: A Bachelor's degree is required, preferably in a scientific or engineering discipline.
  • Over 7 years of proven quality experience in the medical product and device sector, with a strong emphasis on QSR and ISO 13485 compliance and quality assurance.
  • Comprehensive understanding of medical device regulations, including CAPA, NC, and Metrics.

Skills and Competencies:

  • Willingness to travel domestically and internationally as business needs dictate.
  • Experience in communication with both domestic and international regulatory bodies.
  • Strong analytical, strategic, decision-making, and risk assessment skills.
  • Ability to effectively collaborate with process owners and stakeholders across corporate, division, and site levels.
  • Highly developed technical writing and editing capabilities.
  • Excellent organizational, leadership, and interpersonal skills.
  • Proficiency in Microsoft Office and other relevant software applications.
  • Exceptional interpersonal and communication skills, both written and verbal.

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