Quality Management System Specialist II

Position Responsibilities

• Support the Vice President RAQA to develop best practices for Enlitic regulatory and standards compliance.
  
• Assess procedures processes and organizations for compliance with GMP ISO 13485 EU MDR (2017/745) MDSAP Canadian MDR etc. standards and regulations.
  
• Work crossfunctionally to ensure compliance of the QMS system for Document Control CAPA NCR Product Documentation etc.
  
• Participate in QMS Management Reviews
  
• Provide training counsel and handson support to assist Enlitic organizations in maintaining compliance and driving continual improvement in quality system effectiveness.
  
• Maintain the corporate training matrix. Interface with supervisors and managers for training requirements and assign to trainees.
  
• Administrate permissions for access to documents and change control systems.
  
• User and administrative support as needed including updating and drafting of documents in the document control system.
  
• Process new and revised controlled documents in accordance with established policies/procedures.
  
• Perform final review of documents to confirm consistency across documents clarity readability and formatting.
  
• Assure the periodic review and updating of quality documents by monitoring Document Review Due and Review Overdue reports. Contacts owners and escalate as needed.
  
• Maintain associated data log(s) and applicable records in accordance with record retention policies.
  
• Collect and analyze data to demonstrate the adequacy and compliance of QMS processes.
  
• Aid in supplier/vendor management with maintenance of supplier files.
  
• Oversee the corrective and preventive action process in both initiation and management of NCRs and CAPAs including root cause analysis action planning and verifying effectiveness of corrective actions and preventive actions.
  
• Provide support Internal External Quality System Audits
  

Requirements

Location

• Fort Collins Northern Colorado Area or Remote
  

Education

• Bachelor of Science degree in a life science or other similar technical degree
  

Experience

• 35 years of work experience in the medical device or pharma industry. Experience with Software as a Medical Device preferred.
  
• 3 years of direct work experience within a quality management system
  
• Experience with Quality Management System Inspections and Audits for GMP ISO MDSAP EU MDR (2017/745) audits.
  
• Proficiency in validation practices to include Software Products Process Equipment networks servers and operating systems.
  
• Experience with MasterControl Software (or similar Document Control System)
  
• Excellent interpersonal skills: ability to work in crossfunctional teams.
  
• Ability to think clearly analyze processes and provide solutions.
  
• Ability to handle simultaneous tasks and prioritize accordingly.
  
• Excellent communication skills (written verbal and presentation).
  
• Proficiency with a full suite of MS Office Adobe and Google standard applications.
  
• Knowledge of HIPAA and/or GDPR requirements a plus.
  

ISO/QMS Requirements

• Understand and practice all requirements of EN ISO 13485:2016 ISO 13485:2016 MDSAP including 21 CFR 820 QMS Manual Process Flows and Work Instructions. Experience with EN ISO 62304:2006 a plus.
  
• Comply with applicable regulatory requirements (including but not limited to MDSAP participating countries and CE Marking).
  
• Support Internal and External audits.
  

Benefits

Our people love working here because of our collaborative environment and the opportunity to solve unique real world problems.

• Health vision and dental insurance

• Company paid Short Term Disability

• Company paid Long Term Disability

• Company paid employee Life Insurance

• Up to 6% 401k match

• Unlimited Paid Vacation

• $150 a month health and fitness stipend