Quality Engineer/ Sr. Quality Engineer

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy.

Associate Quality Engineer 

Location: Santa Clara, CA. Able to be onsite 5 days a week.

General Responsibilities:

• Provide Quality Department support for SI-BONE products, ensuring that our actions result in meeting our customer needs while maintaining compliance with federal law and applicable standards.
• Responsible for performing all duties in compliance with all applicable worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual.
• Investigate and review SI-BONE medical device complaints in conjunction with Regulatory Affairs.
• The Quality Engineer must act and conduct company business in an honest, ethical and lawful manner, consistent with the company’s Code of Conduct, other company policies and the AdvaMed Code of Conduct and/or any other applicable industry code(s) of conduct. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

Specific Responsibilities and Skills:

• Investigate and review SI-BONE medical device complaints to help identify root causes, solutions, and trends.
• Write protocols and reports for activities such as sterilization validation, cleaning validation, biocompatibility testing, and packaging validation for New Product Development
• Support New Product Development activities, such as assessment and characterization of design, process, and use risks, design verification and validation (V&V) testing
• Develop requirements for sterilization and monitoring of sterilization and endotoxins for new products
• Support and write reports for real-time shelf life testing as part of packaging validation testing of new products
• Advise the manager of factors that may affect quality of the product, initiate reports for deviations and non-conforming materials, and provide guidance/options and ideas for corrective actions and preventive actions (CAPA)
• Perform Quality role for Sustaining Engineering, New Product Development, Design Change (DC) projects and Non-Standard Products (NSPs)
• Assist the Quality team daily to accomplish efficient and effective review and approval of records as assigned including, but not limited to calibration and maintenance work, procedures, validation protocols, validation reports, deviations and change controls
• Monitor and ensure compliance to internal quality system and external industry regulations
• Perform activities pertaining to supplier audits, i.e. audit plans, audit execution, audit reports
• Handle supplier changes and work with Engineering and other departments as appropriate to implement changes in standard operating procedures
• Develop and maintain inspection and Quality control procedures
• Provide direction in developing supplier and incoming inspection plans, sampling plans, inspection, and acceptance criteria for new products
• Provide direction for supplier controls for new products, DCs, and NSPs, including performing vendor audits and evaluations
• Help handle and maintain ASL for new products, DCs, and NSPs, and support Sustaining suppliers as required
• Support CAPAs, NMRs, Deviations, Extension/Scope Changes for new, sustaining products, DCs, and NSPs
• Assist in developing and improving departmental procedures and other controlled documents
• Evaluate adequacy of specifications for new or modified process designs
• Participate in process and technical design reviews and design reviews that are part of five phase device development
• Develop, review, and approve process and equipment validations/qualifications for Sustaining, New Product Development and DC applications
• Perform new product process evaluations, including process capability studies, to identify areas for improvement and to reduce variability and lower total quality costs
• Assist Regulatory Affairs and Engineering personnel in new product/process design to assure effective control procedures are established
• Support internal/external audits to assess compliance to standards and to the internal QMS
• Assist in development, maintenance, and reporting of department metrics
• Develop/update hazard analyses and FMEAs
• Support the management of eQMS systems including MasterControl
• In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485 or ISO 14971), the employee has the authority to hold any product or Quality documentation from shipment or further processing. The employee has the responsibility and authority to report any instances to Quality management and/or Regulatory
• Support the SI-BONE Quality System
• Other duties as assigned

Knowledge, Education and Experience:

• Bachelor’s degree in engineering or technical science
• 5+ years of directly relevant experience with experience in FDA/cGMP or other regulated environment(s)
• Experience in software validation preferred
• ASQ CQE certification preferred
• Knowledge of industry standards (21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, etc.)

Expertise and Attributes:

• Knowledge and familiarity of applicable regulations/standards (e.g. ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971) as required to perform the job function
• Experienced in QMS requirements and able to provide guidance on industry practices. This includes design control, production and process controls, supplier controls, corrective and preventive action, management review, and non-conforming material controls
• Demonstrated ability to drive and deliver innovative, effective, and timely solutions. Ability to mentor others in best practices and industry standards
• Demonstrated ability to acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements
• Strong knowledge of statistical quality tools with process capability and statistical quality control methodologies; demonstrated ability to determine sampling plans based on confidence and reliability
• Experienced with managing and developing suppliers
• Excellent verbal and written communication skills
• Must be a team player

Salary range:  $113,000 - $153,000. The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors.

Supplemental pay: bonus and stock

There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits, please visit www.si-bone.com/risks.

We are aware of active recruitment scams using the SI-BONE name, in which individuals pose as our recruiters and post fake remote job openings and make fake job offers on the Internet. Please note, we will never make an offer of employment without conducting multiple rounds of interviews face-to-face using secure video-conferencing technology. We will never ask candidates to cash checks or make a payment in order to be considered for a position. SI-BONE only uses company email addresses, which contain “@si-bone.com” to communicate with candidates.

If you believe you’ve been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency at https://www.cisa.gov/be-cyber-smart/report-incident learn how to report it.