The Quality Engineer will join our Quality Engineering team, focusing on New Product Introduction (NPI) activities. This role ensures the successful development and launch of high-quality implantable and non-implantable spinal surgery devices through compliance with regulatory, contractual, and quality system requirements. The Quality Engineer will develop, improve, and implement quality methods and systems, working on cross functional teams in a regulated environment to ensure the safety, reliability and efficacy of products and processes.
Essential Duties and Responsibilities- Support New Product Development as primary QE for mechanical instruments and support mechanical implants. Manage multiple concurrent major and minor projects.
- Support Design Controls to ensure efficient, effective, and compliant new product launches.
- Support the qualification of legal manufacturers (OEM) for distributed products.
- Support Material Review Board (MRB) activities, nonconformance investigations and disposition decisions, manage rework and deviation activities, and participate in Supplier Review Board (SRB) reviews.
- Develop inspection plans and custom gauging based upon required measurement and tolerances.
- Support Change Order review for drawings, considering Design for Manufacturing (DFM) and Design for Inspection (DFI).
- Act as liaison between supplier and company for quality related concerns or issues. Technical interface with contract manufacturers.
- Support validation (IQ, OQ, and PQ) development and execution internally and at suppliers as needed.
- Support Risk Management efforts in accordance with ISO 14971; conduct preliminary risk assessments for projects. Support Failure Mode and Effects Analysis (FMEA) for designs and processes.
- Support Field Retrieval Assessment (FRA) and Health Hazard Evaluation (HHE) as needed.
- Support MDSAP, FDA, ISO, and other regulatory audits as needed.
- Apply external standards and guidance documents to project / product specific application.
- Support Supplier Corrective Actions (SCARs) and Corrective and Preventive Actions (CAPAs).
- Perform other duties as assigned.
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.
- Knowledge of mechanical inspection methods and equipment.
- Ability to read, analyze, and interpret blueprints, including GD&T.
- Ability to solve complex problems to root cause and prevent re-occurrence (CAPA).
- Ability to process data, interpret data trends, and make basic recommendations based on findings.
- Knowledge of statistical analysis techniques, sampling plans, capability studies, Minitab, or equivalent statistical software preferred.
- Experience supporting medical device design controls, process validation, supplier quality, or manufacturing quality in a regulated environment preferred.
- Familiarity with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, MDSAP, and ISO 19227 preferred.
- Ability to troubleshoot and manage priorities across multiple projects based upon ATEC business priorities.
- Strong technical writing skills, including ability to write protocols, reports, and procedures.
- Ability to effectively interact with all levels of the organization.
- Shows desire and ability to take on small leadership roles within projects, effective communication and collaboration with team members.
- Ability to develop and maintain strong working relationships with internal and external customers and suppliers.
- Excellent verbal and written communication, ability to resolve minor conflicts, collaborative teamwork.
- Demonstrates tenacity in overcoming obstacles; proactive in taking initiative.
- Knowledge of SolidWorks or other CAD software preferred.
- Detail oriented.
- Good decision-making skills and judgment.
- Ability to develop plans and strategies and execute to completion.
- Must be able to travel up to 5% of the time.
Education and Experience- Minimum Bachelor's degree (BS) from a four-Year College or university in Mechanical, Industrial and Systems, Biomedical, or Manufacturing Engineering or equivalent.
- Or equivalent combination of education and experience may be considered.
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. $75,000 to $90,000 Full-Time Annual Salary
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. 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
