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Head of Quality Assurance Engineering
2 months ago
Position: Director of Quality Engineering - Orthopedic Division
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 exceptional quality standards for our medical device offerings, particularly in spinal and orthopedic technologies. The successful candidate will bring substantial experience in the medical device sector, especially within the orthopedic field, along with a robust foundation in quality engineering, regulatory adherence, and leadership.
Key Responsibilities:
- Guide and nurture the Quality Engineering team, promoting a culture centered on quality, innovation, and ongoing enhancement.
- Engage with cross-functional teams, including Research & Development, Manufacturing, and Regulatory Affairs, to integrate quality throughout the product lifecycle.
- Formulate and execute quality engineering strategies that align with organizational objectives and regulatory mandates.
- Supervise the creation, implementation, 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 preparations for and actively participate in regulatory audits and inspections.
- Support product development initiatives 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 execution of process validation, verification, and qualification activities for both new and existing products.
- Champion continuous improvement efforts to elevate product quality, minimize defects, and enhance operational efficiency.
- Utilize data-driven methodologies to pinpoint trends, root causes, and improvement opportunities.
- Implement corrective and preventive actions (CAPA) and assess their effectiveness.
- Manage supplier quality initiatives, including supplier audits, performance assessments, and the development of supplier quality agreements.
- Collaborate closely with suppliers to ensure the reliable delivery of high-quality components and materials.
- Oversee the establishment and maintenance of the company’s risk management processes, including Failure Mode and Effects Analysis (FMEA) 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 sector, with a focus on 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 a commitment to data-driven decision-making.
- Excellent communication and interpersonal skills, with the capacity to collaborate effectively across departments and with external partners.
- Certification in quality management (e.g., CQE, CQA, Six Sigma) is highly desirable.
