- 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 cross-functionally to ensure compliance of the QMS system for Document Control, CAPA, NCR, Product Documentation, etc.
- Participate in QMS Management Reviews
- Provide training, counsel, and hands-on 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
- Fort Collins, Northern Colorado Area or Remote
- Bachelor of Science degree in a life science or other similar technical degree
- 3-5 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 cross-functional 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.
- 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.
- 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
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Quality Management System Specialist II - Fort Collins, United States - Enlitic
Description
Job DescriptionPosition Responsibilities
Location
Our people love working here because of our collaborative environment and the opportunity to solve unique real world problems.
