Senior Quality Engineer

Overview

SINTX is seeking a Senior Quality Engineer to ensure that our products meet specified standards and comply with regulatory requirements. The ideal candidate will have a keen eye for detail and excellent problem-solving skills. This role oversees product quality by developing quality and inspection plans & fixtures, implementing control systems, conducting product tests, and identifying defects to ensure compliance with standards.

This individual will analyze quality data, recommend process improvements, and collaborate with cross-functional teams and oversee the QC lab.

• Work closely with internal teams to maintain product conformance with drawings and specifications through incoming inspections, in process, and final inspections
• Help design and fabricate inspection fixtures as needed
• Read and interpret technical prints, drawings, and production specifications, including GD&T
• Gather and organize data for creation of inspection plans, ensuring all required information is complete and accurately represented
• Oversee CAPA and Customer Feedback processes ensuring thorough investigation and timely completion
• Participate in MRB with Manufacturing and Production Engineering to review and disposition suspect or non-conforming products
• Report and track any significant deviations from quality standards and recommend corrective and preventive actions
• Oversee cleaning and packaging validations, biocompatibility testing and sterilization processes for implantable and non-implantable devices
• Establish and present regular training for employees on quality issues and develop programs to encourage each employee to perform quality management as part of operations
• Participate in new product development to ensure proper quality management plans and support qualification of new suppliers, development and approval of new product documentation
• Serve on project teams and risk management teams as a Quality Assurance representative
• Write departmental Standard Operating Procedures (SOPs);
  Review and approve SOPs, drawings, and material specifications
• Audit suppliers to ISO 13485 and 21 CFR 820 requirements; review issues with suppliers and issue corrective action requests
• Review and approval of equipment qualifications and equipment maintenance
• Complete quality surveys received from current or potential customers
• Perform internal audits of the quality system to ensure compliance to ISO and FDA requirements and internal audits of the production processes for conformance to internal procedures and applicable standards
• Oversee FDA, ISO, and other external audits of the quality system
• Initiate / Approve Change orders within the quality system and actively participate in the Documentation control process
• Oversee functions for QA Specialist and employee training
• Review production work orders for completeness and approval for release to finished goods
• Perform other related duties as assigned

• Bachelor’s degree in biomedical, mechanical or similar engineering field
• 5-10 years’ experience as a quality engineer, preferably in a production or similar environment
• Experience with interpreting and understanding GD&T and ability to read and interpret technical drawings and schematics for parts
• Knowledge of quality systems and measurement systems
• Strong knowledge of quality planning and lean manufacturing or similar methodology
• Knowledge of ISO 13485 and/or ISO 9001
• Experience managing supplier quality
• Experience managing quality technicians or similar staff
• Previous experience in manufacturing environment
• Industry certification such as Certified Quality Engineer or Certified Auditor, a plus
• Ability to utilize CAD software such as Solid Works, a plus
• Proficiency in Microsoft Office

Occasional travel, expected to be less than 10%, but may fluctuate based on company needs (i.e. supplier audits, etc.)