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.

Roles and Responsibilities:

· 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 SOP’s, 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

Minimum Qualifications:

· 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 SolidWorks, a plus

· Proficiency in Microsoft Office

Travel

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

About SINTX Technologies

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