Senior Quality Systems Specialist

2 weeks ago

Minneapolis, Minnesota, United States Tactile Medical Full time
Job Title: Senior Quality Systems Specialist

At Tactile Medical, we are seeking a highly skilled Senior Quality Systems Specialist to join our team. This role is responsible for leading and maintaining quality system procedures and processes, ensuring product quality and safety in compliance with medical device regulations (ISO 13485, 21 CFR 820).

Key Responsibilities:
  • Quality Systems Development: Develop and maintain quality systems, processes, and procedures.
  • CAPA Management: Oversee the corrective and preventive action system.
  • Supplier Evaluation: Ensure supplier evaluation and monitoring processes meet quality system requirements.
  • Risk Management: Coordinate risk assessments and associated actions throughout the product life cycle.
  • Training: Provide training on quality management system requirements.
  • Audits: Perform/support internal and supplier audits and assist in preparation for external audits.
  • Continuous Improvement: Identify areas for improvement and lead or participate in projects.
  • Document Control: Develop, implement, and maintain document control systems and procedures.
  • Regulatory Compliance: Ensure compliance with regulatory requirements and company standards.
  • Document Lifecycle Management: Manage the document lifecycle, including creation, review, approval, distribution, and archiving.
  • Database Maintenance: Oversee the maintenance of document control databases and software.
  • Project Leadership: Lead small, prioritized projects that support departmental objectives.
  • QMS Process Management: Process DCRs and deviations to ensure compliance.
Qualifications:
  • Education & Experience: 4+ years' experience in Quality Management Systems and/or Document Control.
  • Preferred Qualifications: Bachelors Degree, Lead auditor certification through an accredited organization, experience working with audit findings, corrections, and corrective actions, medical device, pharmaceutical, and/or biotech experience, certification in Document Control or Records Management, previous experience with Electronic Document Management Systems.
Knowledge & Skills:
  • Attention to Detail: Ensuring accuracy in document management and control processes.
  • Organizational Skills: Managing and maintaining large volumes of documents efficiently.
  • Technical Proficiency: Strong proficiency with document management software and systems and Microsoft Office Suite.
  • Regulatory Knowledge: Understanding of industry standards and regulatory requirements.
  • Communication Skills: Effectively conveying information and collaborating with various departments.
  • Leadership: Mentoring newer staff and managing document control projects.
  • Problem-Solving: Identifying and resolving issues related to document control.
  • Time Management: Prioritizing tasks and managing time effectively to meet deadlines.
  • Analytical Skills: Analyzing data and preparing reports on document control activities.
  • Adaptability: Ability to prioritize and deliver on key initiatives in a dynamic environment.

Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts.

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