Quality Engineer, Sustaining

Responsibilities

• Support Material Review Board (MRB)
• Develop and revise inspection methods, gages, and associated drawings and procedures
• Support Engineering Change Order Review and perform Design For Manufacturing activities
• Act as a technical interface with contract manufacturing
• Support suppliers in performing IQ, OQ, and PQ processes
• Provide statistical support to analyze manufacturing processes and recommend controls
• Lead Risk Management efforts in accordance with ISO 14971
• Lead continuous improvement projects and participate in regulatory audits

Requirements

• Bachelor’s degree in Mechanical, Industrial, Systems, Biomedical, or Manufacturing Engineering
• 3+ years of related experience in medical device quality
• Knowledge of 21 CFR Part 820 and ISO 13485
• Experience with mechanical inspection methods and equipment
• Proficiency in SPC, DOE, and statistics
• Ability to read and interpret blueprints and GD&T
• Proficiency in technical writing for protocols and reports
• Knowledge of SolidWorks or other CAD software
• Ability to travel up to 10%

Preferred Qualifications

• Six Sigma Black Belt
• ASQ CQE/OE certification

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave
• Short Term & Long Term Disability
• Free Food & Snacks
• Stock Option Plan