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Head of Quality Assurance Engineering
2 months ago
Position: Director of Quality Engineering - Orthopedic Sector
Location: Irvine, CA (primarily on-site)
Overview:
BioTalent is in search of a seasoned Director of Quality Engineering to spearhead our Quality Engineering division, ensuring the utmost quality standards for our medical device offerings, particularly in spinal and orthopedic domains. The successful candidate will possess significant experience in the medical device sector, with a strong emphasis on quality engineering, regulatory adherence, and leadership capabilities.
Key Responsibilities:
- Guide and develop the Quality Engineering team, promoting a culture centered on quality, innovation, and ongoing enhancement.
- Engage with interdisciplinary teams, including Research & Development, Manufacturing, and Regulatory Affairs, to embed quality throughout the product lifecycle.
- Formulate and execute quality engineering strategies that are in line with organizational objectives and regulatory mandates.
- Supervise the establishment, execution, and upkeep of quality systems in accordance with ISO 13485, FDA QSR, and other pertinent regulatory frameworks.
- Guarantee that all products fulfill or surpass customer expectations and regulatory standards.
- Lead the preparation for and actively participate in regulatory audits and inspections.
- Assist product development teams by offering quality engineering insights in design control, risk management, and process validation.
- Ensure the completeness, accuracy, and compliance of Design History Files (DHF), Device Master Records (DMR), and other quality documentation.
- Oversee the implementation of process validation, verification, and qualification activities for both new and existing products.
- Champion continuous improvement initiatives aimed at enhancing product quality, minimizing defects, and boosting operational efficiency.
- Utilize data-driven methodologies to identify trends, root causes, and areas for enhancement.
- Implement corrective and preventive actions (CAPA) and assess their effectiveness.
- Manage supplier quality processes, including supplier audits, performance assessments, and the formulation of supplier quality agreements.
- Collaborate closely with suppliers to ensure the reliable delivery of high-quality components and materials.
- Oversee the development and maintenance of the company's risk management protocols, including FMEAs and risk assessments.
- Ensure that risk management practices are integrated into all phases of product development and manufacturing.
Qualifications:
- Bachelor's degree in engineering or a related discipline; advanced degree preferred.
- A minimum of 10 years of experience in Quality Assurance and Quality Engineering within the medical device industry, particularly in orthopedics.
- Comprehensive knowledge of FDA regulations, ISO 13485, and other relevant standards.
- Demonstrated experience in leading quality engineering teams and managing intricate projects.
- Strong grasp of design control, process validation, and risk management in the context of medical devices.
- Exceptional problem-solving abilities and the capacity to make informed, data-driven decisions.
- Excellent communication and interpersonal skills, with the capability to collaborate effectively across departments and with external partners.
- Certification in quality management (e.g., CQE, CQA, Six Sigma) is highly desirable.
