Company:
Tactile Medical
Location: Minneapolis
Closing Date: 18/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Overview:
The Senior Quality Systems Specialist 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). This role also manages and oversees the document control processes and systems within the organization, ensuring all documents are properly controlled, maintained, and accessible to authorized personnel.
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 DCR’s and deviations to ensure compliance.
Identify areas of improvement and/or lead or participate in continuous improvement projects.
Perform all job duties while adhering to HIPAA requirements.
Cross-train and backup the team to ensure continuous support.
Other duties as assigned.
Qualifications:
Education & Experience
Required:
4+ years' experience in Quality Management Systems and/or Document Control.
Preferred:
Bachelor’s Degree.
Lead auditor certification through an accredited organization (e.g. ASQ, notified body, etc.).
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.
An understanding of FDA 21 CFR 820, ISO 13485 documentation requirements, especially pertaining to document control, training, quality records, and design control.
Ability to effectively train and educate stakeholders, partners, and management on QMS and Document Control.
Below is the starting salary range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.:
$69,400 - $97,125
Additional benefits::
exempt - 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. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.
The Senior Quality Systems Specialist 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). This role also manages and oversees the document control processes and systems within the organization, ensuring all documents are properly controlled, maintained, and accessible to authorized personnel.
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 DCR’s and deviations to ensure compliance.
Identify areas of improvement and/or lead or participate in continuous improvement projects.
Perform all job duties while adhering to HIPAA requirements.
Cross-train and backup the team to ensure continuous support.
Other duties as assigned.
Qualifications:
Education & Experience
Required:
4+ years' experience in Quality Management Systems and/or Document Control.
Preferred:
Bachelor’s Degree.
Lead auditor certification through an accredited organization (e.g. ASQ, notified body, etc.).
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.
An understanding of FDA 21 CFR 820, ISO 13485 documentation requirements, especially pertaining to document control, training, quality records, and design control.
Ability to effectively train and educate stakeholders, partners, and management on QMS and Document Control.
Below is the starting salary range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.:
$69,400 - $97,125
Additional benefits::
exempt - 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. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.
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