Total Quality Senior Specialist jobs in Oceanside, CA

The primary responsibility of the Senior Quality Assurance Specialist includes supporting ATEC's quality system in compliance with ISO 13485, 21CFR820, and MDSAP. This position will support audits, ad-hoc risk assessments (including HHEs), CAPAs, Quality Planning, system process development, and occasionally support Document Control and Compliance Departments. This role supports the development and operation of the Quality Management System (QMS) at Alphatec Spine. This position also supports compliance to applicable domestic and international regulatory medical device regulations such as Part 820, 7, 806, 1271, ISO 13485, Australian Therapeutic Goods (TGA), New Zealand (Medsafe), and Japan (MHLW/PMDA).

Essential Duties and Responsibilities

• Establishes systems to assure compliance with domestic (21CFR820) and international regulations (Australia: Australian Therapeutic Goods Administration, New Zealand: Medsafe, Japan: MHLW/PMDA)
• Leads the changes for QMS procedures and policies to ensure compliance to ISO 13485 and specific country requirements. Partners with appropriate stakeholders to define, recommend, and implement QMS process improvements.
• Plans and coordinates quality/compliance activities, identify road blocks, and strategizes on various compliance paths for new products and significant changes.
• Conducts audits (both internally and externally)
• Lead and assist in the development, implementation, and verification of corrective action and preventive action (CAPA) program
• Review documents to ensure regulatory compliance
• Designs, implements and maintains the quality systems ensuring compliance requirements
• Supports internal QMS audits as needed for compliance.
• Assists with Health Hazard Evaluations (HHE) with cross functional team members.
• Leads product complaint investigations as needed and drive to closure related to quality/compliance issues in a timely manner by working with various functions including but not limited to the Quality Control, Quality Engineers, and Compliance team members to determine root cause(s), evaluate, disclose and appropriately remedy risks and deficiencies.
• Supports development of key QMS metrics. Provides analysis and reporting for Monthly Trend and Management Review Meetings.
•   Performs other duties as assigned or required.