SINTX Technologies is dedicated to providing comprehensive advanced ceramic technology solutions across a wide range of industries. We draw upon our strengths in innovation, quality, and advanced manufacturing. These strengths have been distilled from our origins developing technical ceramic and composite components for biomedical, aerospace, defense, and energy markets. We have a new position with our company as a Senior Quality Engineer.

Job Description

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.)