Medical Device Quality Assurance Manager

The QA Manager is responsible for providing leadership in Quality Assurance and overseeing the checking, monitoring and improving the various components of the Quality Management System (QMS) including document control, CAPA, Deviation, Quality Investigation, Change Control, Product Complaint and other QMS processes. This role will supervise QA personnel, interface with senior management of the quality organization and will collaborate with internal peers, management, regulatory officials, auditors, contractors, and consultants as well as external vendors.

Key Responsibilities

• Based on knowledge of EN ISO 13485:2016, and 21 CFR Part 820, audit plant processes to ensure both internal and external regulations and standards are being adhered to. Third party and regulatory inspection preparation, participation, and support
• Ensure auditing and manufacturing documentation is kept up to date by the responsible departments, i.e. internal audit plan and records, calibration & preventive maintenance, manufacturing SOPs, test methods, etc
• Manage periodic and ongoing review of documents and procedures to ensure company processes comply with ISO and cGMP standards
• Support, maintain and identify continuous improvements of core processes and QA operations as related to product quality and overall compliance
• Ensure timely review and approval of documents including, but not limited to, QMS, internal procedures, vendor documents, executed and unexecuted batch records, QC testing data and validation protocols
• Ensure organization of the periodic/annual review of standards and documents
• Participate in product complaint investigations, annual product review, material review boards, as needed
• Perform and document investigations and work with management to implement corrective action
• Issue and manage Corrective and Preventive Actions (CAPAs) and Nonconformances (NCMRs).
• The QA Manager will support the Director of QA when modifications, improvements or expansion of ExThera’s Quality Management System are required
• Responsible for performing work activities in accordance with the procedures and requirements of ExThera Medical’s Quality Management System and Quality Policy and strive to achieve the Quality Objectives applicable to this position
  
  

What You Will Bring

• Bachelor's degree, preferably in science
• Experience in a Quality Assurance role within the Medical Device or Pharmaceutical industry
• Minimum 10 years in a quality role in medical device or pharmaceutical company
• Understanding of and ability to apply elements of EN ISO 13485:2016, and 21 CFR Part 820
• Experience using document control software system, i.e. MasterControl
• Experience performing audits
• Experience in root cause analysis
• Significant work experience using standard MS Office software, particularly Word, Excel, and PowerPoint
• Analytical skills to gather and interpret data
• Critical/logical thinking to identify problems and provide solutions that ensure quality and efficiency
• Strong organizational skill
• Strong attention to detail and accuracy
• Excellent communication and interpersonal skills
• Must be easily adaptable to changing priorities and deadlines
• Self-starter and a team player that will thrive in an entrepreneurial environment
  
  

Relocation benefits are not offered for this role. This is an onsite role with a work location in Martinez California. The expected salary range for this position based on the primary location of Martinez, Ca is $120,450 and $145,956. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

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