Senior Supplier Quality Engineer
Alphatec Spine, United States
Job Description
The Senior Supplier Quality Engineer is responsible for developing suppliers to provide products and services to ATEC. Works cross-functionally in the development and or maintenance of products and services. The Senior Supplier Quality Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validations as well as statistical analysis and metrics to analyze those systems and processes being measured.
Essential Duties and Responsibilities
- Conduct on-site audits and supplier performance evaluations based on company procedures and ensures compliance with the supplier’s management system.
- Generate supplier audit schedules and ensure completion of audits per audit schedule.
- Provide overall maintenance of the Approved Supplier List.
- Lead the supplier selection, approval, classification, and development through a combination of audits and product or process qualifications.
- Provide supplier trend results for Management Review
- Support second sourcing and design transfer to manufacturing for sustaining product.
- Support qualification of legal manufacturers for distributed products.
- Represent supplier quality engineering in technical teams, setting priorities for corrective action efforts and leading related failure investigations as required.
- Act as liaison between supplier and company for quality related concerns or issues.
- Coordinate Manufacturer Qualification activities including but not limited to PQ’s, GRR, correlation studies and process development.
- Manage SCAR process from beginning to end, implementing and follow-up of corrective and preventive actions.
- Provide statistical support to suppliers allowing both to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification.
- Perform customer complaint investigations on products manufactured by suppliers.
- Participate in FDA, ISO and other regulatory audits.
- Traveling is approximately 30% as required.
- Other duties as assigned.
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.
- Ability to perform supplier audits in multiple commodities (e.g. machining, injection molding, packaging, sterilization, biologics, electronics)
- Direct experience with implantable devices, instrumentation and disposables, in a regulatory environment (GMPs, ISO13485) required
- Must have knowledge of Quality Engineering discipline, including statistics.
- Thorough understanding of the FDA Quality System Regulations (21 CFR Part 820), ISO 13485 and ISO 19227. Recommended knowledge of AATB Regulations and 21 CFR Part 1271
- Thorough knowledge of mechanical inspection methods and equipment
- Thorough knowledge of SPC, DOE, Gage Ramp;R studies, probability and statistics
- Ability to read, analyze, and interpret blueprints utilizing ANSI 14.5 Y(GDamp;T)
- Ability to write protocols, reports, procedures, and work instructions
- Ability to effectively interact with all levels of the organization
- Ability to develop and maintain strong working relationships with internal and external customers and suppliers
- Ability to solve complex problems to root cause and prevent re-occurrence
- Detail oriented
- Good decision making skills and judgment
- The ability to execute plans/strategies to completion
Education and Experience
Bachelor’s degree (BS) from a four-year college or university is required, preferably in Mechanical, Biomedical, Industrial or Manufacturing Engineering.
Minimum of 5 years’ experience in medical industry/device manufacturing environment is preferred.
Certificates, Licenses, Registrations
ASQ CQE (Certified Quality Engineer), ASQ CQA (Certified Quality Auditor), and Lead audit certification preferred.
Strong working knowledge of DMAIC/Six Sigma problem solving process preferred.
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 fed