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Quality Assurance Systems Specialist
2 months ago
Position Overview
This role seeks an individual proficient in sophisticated quality assurance methodologies with a comprehensive understanding of the ISO 13485 Quality standard. Key focus areas encompass statistical process control, performance metrics, customer relations, compliance with ISO, FDA, and GMP regulations. The primary objective of this position is to enhance the quality systems framework within a contract manufacturing setting. Furthermore, this individual will be tasked with the upkeep and enhancement of the Resonetics ISO certified Quality System, concentrating on both customer-related and internal process activities, including surveys and audits.
Key Responsibilities
- Collaborate to establish, document, and uphold all Quality Assurance policies and procedures across all Resonetics facilities, including the maintenance of the Resonetics Quality Manual and associated procedures.
- Engage with customer quality representatives to address issues and resolve customer complaints.
- Work alongside relevant parties to address corrective and preventive actions.
- Support customer and regulatory audits.
- Oversee assigned production readiness tasks to ensure quality awareness is integral to process development.
- Contribute to the creation and refinement of standard operating procedures, incorporating input from functional departments and participating in process development.
- Lead quality enhancement initiatives across various sites and provide updates on progress.
- Conduct regular reporting of activities and key performance indicators.
- Act as a customer liaison for quality system-related matters and may take on project management responsibilities for specific customer applications.
- Educate Resonetics personnel on quality principles and procedures.
- Administer and enhance Resonetics' quality management system, including its quality information systems.
Qualifications
- At least 5 years of experience in a Quality Systems role.
- Proven experience with ISO 9001 or ISO 13485 or similar quality and regulatory frameworks.
- Excellent writing skills.
- Bachelor's degree in a technical field or equivalent experience.
Compensation
$60,000-$90,000
Resonetics is dedicated to ensuring equal opportunity for all employees and applicants, without regard to race, color, religion, sex, sexual orientation, age, national origin, ancestry, disability, or veteran status. Hiring decisions are based on Resonetics' operational needs and the merit of applicants, including qualifications, experience, capability, availability, cooperation, and job performance.
