Alphatec Spine
Quality Assurance Specialist II
Carlsbad, California, United States · Mid · Full-time
Sponsorship not specified$95k-$110kDetected 3 days ago
ComplianceExcelSAPAuditingGMPFDA RegulatoryMedical DevicesLeadershipCommunicationMicrosoft Office
About the role
- The primary responsibility of the Quality Assurance Specialist II includes supporting ATEC's quality system in compliance with ISO 13485, 21CFR820 and MDSAP.
- Plans and coordinates quality/compliance activities, identify roadblocks, and strategizes on various compliance paths for new products.
- Assists with Health Hazard Evaluations (HHE) with cross functional team members.
Responsibilities
- This position will ensure that auditing activities to maintain compliance, and support Document Control and Compliance Departments.
- This role supports the development and operation of the Quality Management System (QMS) at Alphatec Spine.
- Partners with appropriate stakeholders to define, recommend and implement QMS process improvements.
- Review documents to ensure regulatory compliance Designs, implements and maintains the quality systems ensuring compliance requirements Supports internal QMS audits as needed for compliance.
- Supports development of key QMS metrics.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requirements
- Performs other duties as assigned or required.
- The requirements listed below are representative of the knowledge, skill, and/or ability required.
Compensation
- Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $95,000 to $110,000 Full-Time Annual Salary
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