Job Title: Senior Quality Assurance Manager

Job Summary: The Senior Quality Assurance (QA) Manager is responsible for leading a team of Quality Engineers, Document Control Specialists, and Quality Assurance Specialists. This role entails overseeing various aspects of quality management including material release, batch record review, product release, document control, training, corrective/preventive actions, audits, compliance, and continuous improvement initiatives. The Senior QA Manager will provide technical guidance, lead improvement projects, coordinate audits, manage the Corrective and Preventive Action (CAPA) process, ensure compliance with regulations, and oversee staff training and development.

Duties and Responsibilities:

1. Technical Guidance:

• Provide guidance to Quality Engineers on manufacturing process and product design changes, validation, and risk management activities.
• Ensure compliance with design control elements throughout product development.

1. Improvement Projects:

• Lead the implementation of improvement projects, such as transitioning to electronic Document Control and Training modules.

1. Audit Coordination:

• Lead and coordinate regulatory and internal audits of the Quality Management System (QMS).

1. Supplier Audit Program:

• Provide oversight of the supplier audit program to ensure quality standards are met.

1. CAPA Management:

• Manage the CAPA process to drive continuous improvement.
• Oversee quality data trending activities and present findings to relevant stakeholders.

1. Document Control:

• Manage the Document Control system to ensure compliance with regulations and procedures.
• Write, implement, and approve changes to controlled documents as needed.

1. Training:

• Provide training on quality assurance, internal procedures, and Good Manufacturing Practices (GMP).

1. Compliance:

• Ensure adherence to internal procedures, cGMP production standards, ISO 13485:2016, and FDA QSR.

1. Staff Management:

• Manage QA staff and oversee quality assurance responsibilities.

1. Record Keeping:

• Ensure timely review and approval of manufacturing batch records, inspection records, and nonconformance reports.
• Investigate and close customer complaints and maintain logs of quality-related activities.

Preferred Qualifications:

• ASQ Certified Quality Engineer and/or Certified Quality Auditor/Biomedical Auditor.
• Understanding of Medical Device Risk management.
• Ability to work well under pressure and handle multiple projects.
• Proficiency in compliance regulations, standards, and procedures.
• Strong analytical, interpersonal, and leadership skills.
• Exceptional attention to detail and organizational skills.
• Proficiency in MS Word, Excel, PowerPoint, and Visio.

Preferred Education and Experience:

• Bachelor's degree in a scientific or technical field.
• Minimum 10 years of quality engineering and assurance experience in the medical device industry.
• Minimum 5 years of Quality Management experience.
• Experience in start-up and mid-size company environments.
• Experience with product transfers and integrations.

Knowledge Requirements:

• Working knowledge of ISO 13485:2016 and FDA QSR.