Senior Compliance and Quality Assurance Leader
2 weeks ago
Position Overview: We are seeking a Senior Compliance and Quality Assurance Leader. This role is pivotal in ensuring product adherence to established protocols and regulatory requirements, encompassing responsibilities related to customer feedback, corrective actions, quality strategy, and facility modifications.
Key Responsibilities:
- Facilitate prompt resolution and documentation of customer inquiries, providing accurate solutions to technical challenges and addressing customer concerns.
- Collaborate effectively with internal departments, including customer support, sales, and research and development, to deliver efficient resolutions to customer issues.
- Enhance the company's reputation as a trusted technical resource and industry leader by actively engaging with customers.
- Drive continuous improvement initiatives aimed at boosting productivity, customer satisfaction, and overall engagement.
- Lead compliance activities, including the initiation and closure of corrective action plans, ensuring thorough investigation support.
- Oversee the planning and review of facility change requests, ensuring alignment with quality standards.
- Manage compliant documentation processes, including investigation oversight and customer communication.
- Classify and determine the nature of customer inquiries for effective resolution.
- Coordinate cross-functional efforts related to compliance activities, ensuring timely closure of customer complaints and corrective actions.
- Ensure adherence to applicable standards and procedures related to compliance activities.
- Assist in communications with regulatory bodies as necessary.
- Revise or develop technical support standard operating procedures based on feedback and data analysis.
Qualifications:
- Bachelor's degree with a minimum of 4 years of relevant experience in the medical device sector or a related field; advanced degrees are advantageous.
- At least five years of experience in technical support, customer service, or quality assurance/compliance within the medical device industry.
- Proficient in quality control methodologies and production systems.
- Experience in cytogenetics, cell and tissue cultures, either through education or industry exposure.
- Strong skills in risk management and failure mode effects analysis.
- Exceptional root cause analysis capabilities.
- Proficient in Microsoft Office Suite.
- Demonstrated leadership and decision-making skills.
- Excellent communication and presentation abilities.
- Fluency in English is required; additional language skills are a plus.
Compensation: The salary range for this position is competitive and commensurate with experience and qualifications.
Diversity and Inclusion: Irvine Scientific is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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