Quality Assurance Specialist II

DescriptionThe 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/PMDAAssist 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 complianceDesigns, implements and maintains the quality systems ensuring compliance requirementsSupports 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 environmentStrong written and very communication skills and attention to detailSelf-starting, detailed oriented, quick learner, creative and analyticalCapable of understanding and analyzing complex engineering problemsDemonstrated leadership, and ability to solve problems and communicate issuesUnderstanding of documentation system and managementExperience in an FDA regulated environment desirableMicrosoft 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 organizationAbility to prioritize multiple projectsAbility to resolve conflicting interests and obtain cooperation Education and ExperienceTypically requires a Bachelor’s Degree and minimum of 2 years medical device experienceATEC 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.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).At this time, ATEC Spine does not sponsor employment visas for this position. Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.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 SalaryBenefitsHealth 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 DisabilityFree Food & SnacksStock Option PlanJob SummaryID: 0236CE30C1Department: QualityType: full time