Quality Compliance Manager - Medical Device - Posted Date: October 04, 2021



Job Description

ISO 13485 / 21 CFR 820 / EU MDD/IVD, EU MDR/IVDR/

MAJOR DUTIES AND RESPONSIBILITIES:

? Responsible for direct supervision of Document Specialists and Training/Quality Compliance Specialists
? Ensure Quality Management System procedures are established and maintained in compliance to International, National and Local regulatory requirements
? Identify changes to relevant regulatory requirements and industry standards
? Administer and manage the Standards Gap Assessment log
? Undertake gap assessment activities to newer quality and regulatory requirements
? Work cross functionally to address the identified system gaps and implement changes
? Train the organization to ensure the new requirements are communicated internally
? Provide support to regulatory team for International Product Registration and ensure quality & regulatory compliance to US, Europe and other International regulations for Instruments and Reagents
? Manage the CAPA System
? Maintain compliance of the CAPA system per relevant procedures
? Schedule CAPA Board meetings periodically to facilitate review of ongoing CAPAs
? Coordinate with CAPA owners to ensure assigned action items are completed in an accurate and timely manner
? Manage Good Documentation Practices GDP, cGMP and GLP
? Maintain records on line in Propel and NetSuite. All record should be concise, legible, accurate, and traceable.
? Establish and manage document retention periods for Superseded documents.
? Manage and control Records retention per established criteria and SOP.
? Administer and manage the ECs/Deviations and maintain overall compliance to relevant procedures
? Work cross-functionally with other teams to track and manage EC from initiation through closure
? Manage DHR and Quality records to support
? Applicable SOPs shall be in compliance of cGMP and GLP guidelines
? Manage Employee Training Program
? Administer and manage employee training and ensure overall compliance to relevant Training Plan
? Work cross-functionally with other teams to develop training track and manage timely completion of training
? Work with HR to create and align training plans with roles and responsibilities for internal and external training.
? Manage Internal & External Audit and Inspection System
? Maintain compliance to the Quality Audit procedures
? Serve as subject matter expert for Quality Management System and Compliance related activities during internal and external audits
? Administer and manage the audit findings to address audit non-conformances
? Oversee scheduling and coordination of Management Reviews
? Schedule Management Review and other periodic reviews
? Coordinate with cross functional team members to collect relevant data and compile presentation for the reviews
? Monitor and trend QMS process (CAPA, RMA, NCMR, Audits, Supplier performance etc.) metrics
? Identify and drive Quality Management System continuous improvement activities
? Other relevant duties as assigned

EDUCATION REQUIREMENTS:

? Bachelor?s degree in a related discipline and 5 years experience in medical device quality systems and compliance role. BS in an Engineering field is preferred.
? Statistical Process Control and/or Six Sigma Black Belt certification desired.
? Strong working knowledge of quality tools and process control tools.
? ASQ Certified Quality Manager (CQM) and/or an industry related Technical Certification is a plus.
AppleOne Technical is proud to be an Equal Opportunity Employer. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.

Experience Required

, , Recent IPO Biotech company offers competitive compensation + Comprehensive benefits + (Bonus & stocks options are in plan)
FTE PAY: $DOE + Full Benefits + Bonus
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