Associate Director, Quality Assurance

Job Description

This Associate Director, Quality position provides medical device and combination product (MDCP) support to the site.  Primary responsibilities to include providing overall site leadership to establish and then maintain site ISO 13485 certification.  This position will also ensure new product launches for medical devices and combination products are following applicable regulatory requirements.  The Associate Director will ensure that quality management systems are established and maintained in accordance with ISO 13485 standards. They will also be responsible for leading QMS gap assessments against regulations and company standards, hosting audits from Notified Bodies and FDA, and ensuring compliance with relevant regulations such as 21 CFR Part 4, QMSR, and EU MDR.

The MDCP Associate Director, Quality position is responsible for providing day to day tactical and strategic support to the site’s MDCP program.  Primary responsibilities include ensuring that high standards for MDCP compliance are maintained at the site and that key projects related to these products are supported allowing effective execution.  Additional activities, responsibilities, and competencies include but are not limited to the following:

Compliance:

• Acts as site subject matter expert for MDCP related compliance.  Ensure site operates within established MDCP policies, procedures, ISO standards, and applicable Health Authority regulations.
• Establish and maintain quality management systems compliant with ISO 13485 standards and relevant MDCP regulations.
• Conduct QMS gap assessments against applicable regulations and standards to ensure compliance.
• Stay updated with regulatory changes and industry best practices related to quality management systems and certifications.
• Prepare the company for MDCP related audits by Notified Bodies and FDA, including hosting audits and addressing audit findings.

Delivery:

• Provide Quality support to device assembly, packaging, and other site operations to rapidly resolve concerns and assure compliant and reliable customer supply. 
• Provide Quality Assurance review and approval of MDCP related GMP documentation.
• Collaborate with cross-functional teams to implement corrective and preventive actions based on assessment findings.
• Resolve and escalate MDCP related concerns with the potential to impact product launches or supply.

Cost 

• Ensure that activities are carried out in accordance with departmental budget. 
• Recognize and implement opportunities for efficiency and financial savings. 

People and Team:

• Provide guidance and training to employees on quality requirements and best practices related to MDCP standards and regulations.
• Support a positive culture of inclusion within the Quality team.
• Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents. 
• Build effective relationships with other functional areas as well as stakeholders across the company's network.

Strategic Support and Continuous Improvement:

• Support the company's ISO 13485 certification and lead the site efforts for medical device and combination products launch.
• Participate in continuous improvement initiatives to enhance the overall quality culture within the organization.
• Collaborate with internal and external stakeholders to establish and maintain effective quality processes and systems.
• Identify and implement opportunities for process optimization and efficiency in quality management.

Minimum Education Minimum Requirement and Experience:

• Bachelor’s degree in Science or Engineering related field with eight (8) years of experience working in Quality for a medical device or combination products manufacturing organization.

Required Experience and Skills:

• Demonstrated experience maintaining quality management systems compliant with ISO 13485.
• Thorough understanding of ISO 13485, 21 CFR Part 4, QMSR, and EU MDR.
• Strong communication skills: ability to effectively communicate with cross-functional teams, auditors, and regulatory authorities.
• Attention to detail: meticulous in ensuring compliance with regulations and standards.
• Strong leadership and influencing skills: ability to drive change, influence stakeholders, and lead a team.
• Experience hosting audits by Notified Bodies and FDA.

Preferred Experience and Skills:

• Proven track record in leading QMS gap assessments against regulations and standards.
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