Quality Engineer/ Sr. Quality Engineer

SI-BONE, Inc•Santa Clara, CA

19h•$113,000 - $153,000•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Experience in software validation preferred
ASQ CQE certification preferred

Responsibilities

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