Sr Quality Assurance Manager
2 weeks ago
Position Overview:
Brunel is seeking a highly skilled and experienced Senior Manager of Quality Assurance to join our MA-based client. The Senior Manager of Quality Assurance will be responsible for overseeing all aspects of quality assurance activities related to the design, development, manufacturing, and distribution of their Class II medical devices. This role requires strong leadership abilities, exceptional attention to detail, and a deep understanding of regulatory requirements in the medical device industry.
Key Responsibilities:
Develop and maintain the company's quality management system (QMS) in compliance with relevant regulations and standards, including FDA QSR (21 CFR Part 820) and ISO 13485.
Lead and mentor a team of quality assurance professionals, providing guidance and support to ensure the highest level of quality and compliance across all departments.
Establish and maintain quality objectives and key performance indicators (KPIs) to monitor and improve the effectiveness of the QMS.
Coordinate internal and external audits, including FDA inspections and Notified Body audits, and ensure timely resolution of any findings or observations.
Oversee the review and approval of design control documents, including design inputs, design outputs, verification and validation activities, and risk management documentation.
Collaborate with cross-functional teams to ensure quality and compliance requirements are considered throughout the product lifecycle, from concept to commercialization.
Drive continuous improvement initiatives to enhance quality processes, reduce non-conformances, and optimize efficiency within the organization.
Serve as the primary point of contact for quality-related communications with regulatory agencies, customers, and suppliers.
Stay informed about changes in regulations, standards, and industry best practices, and implement necessary updates to the QMS accordingly.
Represent the quality assurance function in management meetings, providing updates on quality performance and addressing any issues or concerns.
Qualifications:
Bachelor's degree in engineering, life sciences, or related field; advanced degree preferred.
Minimum of 7+ years of experience in quality assurance roles within the medical device industry, with a focus on Class II devices.
In-depth knowledge of FDA regulations (21 CFR Part 820) and ISO 13485 quality management system requirements.
Strong leadership and team-building skills, with the ability to inspire and motivate a diverse team of professionals.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
Proven track record of successfully managing regulatory inspections and audits.
Experience with risk management methodologies, such as ISO 14971, and familiarity with design control processes.
Quality certifications (e.g., ASQ Certified Manager of Quality/Organizational Excellence, ASQ Certified Quality Auditor) are a plus.
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