Quality Assurance Manager

Position Overview:

The Quality Assurance Manager will be responsible for overseeing the Quality Management System and ensuring compliance with regulatory standards. This role involves developing and implementing quality plans, maintaining the document control system and driving continuous improvement initiatives. 

Key Responsibilities: 

•  Develop, implement, and maintain quality assurance policies and procedures.

•  Ensure compliance with FDA, ISO 13485, and other relevant regulatory requirements.

•  Lead and manage the quality assurance team, providing guidance and support.

•  Conduct internal audits and manage external audits by regulatory bodies.

•  Oversee the investigation, root cause analysis and resolution of quality events such as Nonconformance, Customer Feedback, Corrective Action Preventative Actions, etc.

•  Collaborate with cross-functional teams to ensure quality is integrated into all aspects of product development and manufacturing.

•  Monitor and report on key quality metrics and drive continuous improvement initiatives.

•  Provide training and support to staff on quality assurance processes and best practices.

Qualifications:

•  Bachelor's degree in Engineering, Life Sciences, Quality Management, Business Administration or a related field.

•  Minimum of 5 years of experience in quality assurance (medical device industry experience a plus).

•  In-depth knowledge ISO Standards (14385 knowledge a plus).

•  Strong leadership and team management skills.

•  Excellent problem-solving and analytical abilities.

•  Effective communication and interpersonal skills.

•  Experience with JMP, Minitab, or other statistical analysis software.

•  Certification in quality management (e.g., CQE, CQA) is a plus.

Benefits:

• Salary DOE
• Health Insurance
• Employee Assistance Program {EAP}
• SLO County "Family Friendly Employer"
• Profit Sharing
• 401K
• Paid Time Off (PTO)
• Paid Holidays
• Educational Assistance
• Direct Deposit