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Sr. Supplier Quality Engineer

1 month ago

Carlsbad, United States Alphatec Spine Full time

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 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

  • Leads teams and manage product focus groups working with in-house and suppliers.
  • Conducts on-site audits and supplier performance evaluations based on company procedures and ensures compliance with the supplier’s management system.
  • Responsibilities also include being lead supplier quality engineer representative in technical teams, setting priorities for corrective action efforts and leading related failure investigations as required.
  • Liaison between supplier and company for quality related concerns or issues.
  • Provide guidance to suppliers on Alphatec’s quality requirements for sustaining and new product development projects (First Article, PFMEA, control plans, and other tools to ensure conformance of product being received).
  • Support New Product Development.
  • Responsible for supporting Development/Operations Engineering and manufacturing to resolve technical issues and implement corrective and preventive actions.
  • Lead supplier development project/activities.
  • Coordinate Manufacturer Qualification activities including but not limited to PQ’s, GRR, correlation studies and process development.
  • Manages SCAR process from beginning to end, implementing and follow-up of corrective and preventive actions.
  • Trains quality control associates to ensure inspection procedures and processes are followed and accurate. Develop inspection methods and gauges to improve receiving inspection process.
  • 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 10-50% 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.

  • Direct experience with medical instrumentation and disposables, in a regulatory environment (i.e. GMPs, ISO13485, EN46001, etc.) required
  • Must have knowledge of Quality Engineering discipline, including statistics.
  • Thorough understanding of the FDA Quality System Regulations (21 CFR Part 820).
  • Working knowledge of Solid Works CAD software
  • Extensive knowledge of mechanical inspection methods and equipment
  • Extensive knowledge of SPC, DOE, Gage R&R studies, probability and statistics
  • Ability to read, analyze, and interpret blueprints utilizing ANSI 14.5 Y(GD&T)
  • Ability to write reports and procedures
  • Ability to effectively interact with all levels of the organization
  • Working knowledge of lean principals and implementation
  • 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
  • Working knowledge of biocompatibility requirements

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 required.

Supplier qualification and auditing experience required

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 and belt certified a big plus.

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 federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

Alphatec 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. $110,000 to $120,000 Full-Time Annual Salary