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).
Essential Duties and 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.
RequirementsThe 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 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
Education and Experience- 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).
Salary RangeAlphatec 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
Benefits- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Family Leave (Maternity, Paternity)
- Short Term & Long Term Disability
- Free Food & Snacks
- Stock Option Plan
