Quality Engineer, Sustaining

About the role

The Quality Engineer will join our Quality Engineering team, focusing on product sustaining. This role is responsible for supporting the manufacture of high quality implantable and non-implantable spine surgery medical devices by ensuring compliance with contractual and regulatory requirements. Working closely with our NPI QE team, contract manufacturers and quality control, you will ensure only good product goes on shelf.

Responsibilities

• Support Material Review Board (MRB)
• Develop and revise inspection methods, gages and associated drawings and procedures
• Support Engineering Change Order Review
• Perform Design For Manufacturing activities (DFM)
• Technical interface with contract manufacturing
• Support suppliers in performing IQ, OQ and PQ processes
• Provide statistical support to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification
• Lead Risk Management efforts in accordance with ISO 14971
• Lead continuous improvement projects
• Participate in FDA, ISO, and other regulatory audits

Requirements

• Technical Knowledge of both US and International medical device quality system requirements (e.g. 21 CFR Part 820, ISO 13485), and other applicable standards
• Experience supporting on-market / commercialized product
• Knowledge of mechanical inspection methods and equipment
• Knowledge of SPC, DOE, probability, and statistics
• Ability to read, analyze, and interpret blueprints and GD&T
• Ability to solve complex problems to root cause and prevent re-occurrence (CAPA)
• Proficient in Technical Writing (Protocols, Reports)
• Knowledge of Solid Works or other CAD software
• Working knowledge of biocompatibility requirements

Qualifications

• Minimum Bachelor's degree (BS) from a four-Year College or university in Mechanical, Industrial and Systems, Biomedical, or Manufacturing Engineering
• 3+ years related experience and/ or training; or equivalent combination of education and experience

Skills

• Six Sigma Black Belt, ASQ CQE/OE (Certified Quality Engineer/Operational Excellence), preferred

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retailment 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