Senior Quality Assurance Specialist

Location

Carlsbad, CA | United States

Job description

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.

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Experience with quality system elements pertaining to medical devices and QSR, cGMP and ISO 13485, MDSAP, TGA, Medsafe, MHLW/PMDA familiarity is preferred.
• Ability to work independently, but equally in a team environment
• Strong written and communication skills while maintaining high attention to detail
• Self-starting, detailed oriented, quick learner, creative and analytical
• Experience in an FDA regulated environment is desirable, experience as an audit host desirable.
• Microsoft Office knowledge, including Word, Excel. Experience with SAP ERP system, and Agile Product Lifecycle Management System is a plus.
• Ability to communicate effectively with all levels of the organization
• Ability to prioritize multiple projects
• Ability to resolve conflicting interests and obtain cooperation

Education and Experience

• Typically requires a Bachelor’s Degree in Engineering and minimum of 5 years medical device experience

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

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. $105,000 to $120,000 Full-Time Annual Salary

Job tags

Salary