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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Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Internet Publishing
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