Quality Assurance Specialist II

Alphatec Spine•Carlsbad, CA

1d•Onsite

About The Position

The primary responsibility of the Quality Assurance Specialist II includes supporting ATEC’s quality system in compliance with ISO 13485, 21CFR820 and MDSAP. 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. This position also supports compliance to applicable domestic and international regulatory medical device regulations such as Part 820, 1271, MDD 93/42/EEC, ISO 13485:2003, Australian Therapeutic Goods (TGA), Japan (MHLW/PMDA).

Requirements

Experience with quality system elements pertaining to medical devices and QMSR, QSR, cGMP and ISO 13485 and MDSAP familiarity is preferred.
Ability to work independently, but equally in a team environment
Strong written and very communication skills and attention to detail
Self-starting, detailed oriented, quick learner, creative and analytical
Capable of understanding and analyzing complex engineering problems
Demonstrated leadership, and ability to solve problems and communicate issues
Understanding of documentation system and management
Experience in an FDA regulated environment desirable
Microsoft Office knowledge, including Word and Excel, is a strong preference.
Experience with SAP or Oracle Cloud 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
Typically requires a Bachelor’s Degree and minimum of 2 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).

Nice To Haves

Experience with SAP or Oracle Cloud system is a plus.

Responsibilities

Assist in the establish of systems to assure compliance with domestic (21CFR820) and international regulations (Australia: Australian Therapeutic Goods Administration, Japan: MHLW/PMDA)
Assist in implementation of 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 roadblocks, and strategizes on various compliance paths for new products.
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.
Facilitates CAPAs as needed to ensure compliance along with timeliness of completion.
Supports development of key QMS metrics.
Provides analysis and reporting for Monthly Trend and Management Review Meetings.
Assist the complaint handling system in accordance with domestic and international regulatory requirements, as needed.
Performs other duties as assigned or required.