Quality Assurance Manager

SI-BONE, Inc; Santa Clara (CA); On-site; USD 141,000 - 155,000; Full time

Benefits offered by this job

Bonus

Stock options

Job summary

SI-BONE, Inc is seeking a seasoned QA/Quality Engineering professional to drive regulatory compliance, CAPA and quality improvements for its sacropelvic medical devices in Santa Clara, CA.

The role includes leading batch reviews, supplier controls, design control, and audit management, with a focus on delivering compliant products and robust quality systems across the organization.

Qualifications

• Bachelor’s degree in engineering or technical science.
• 6+ years of directly relevant experience in FDA/cGMP or other regulated environments.
• ASQ CQE certification preferred.
• Knowledge of FDA QMSR, ISO 13485, MDR, MDSAP.
• Experience with Design Control, Quality Control, Production Process Controls, Supplier Controls, CAPA, and Non-Conformance.
• Knowledge of regulatory standards for human tissue processing is a plus.
• Strong problem-solving and data analysis skills.
• Ability to develop and implement quality programs.

Responsibilities

• Manage batch reviews and release product to meet FDA/ISO requirements.
• Lead QC Inspectors; review lot history records and RMA inspections.
• Support supplier controls, audits, evaluations, and CAPA processes.
• Manage Sustaining and assist new products; provide input for notified body queries.
• Oversee project initiation to delivery; prepare status reports and budgets.
• Coordinate design/process changes with external suppliers; develop qualification strategies.
• Mentor peers; drive CAPA/Non-Conformance for sustaining products.
• Investigate quality problems; determine root cause and implement corrective actions.
• Create quality metrics and routine inspection data reports.
• Participate in customer complaint investigations; manage software validation and audits.

Skills

Quality Assurance

Team leadership

Root cause analysis

Statistical quality tools

Verbal and written communication

Mentoring

Regulatory knowledge

Education

Bachelor’s degree in engineering or technical science

ASQ CQE certification preferred

Tools

ERP System (QAD)

Quality management tools

Job description

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.

SI-BONE® is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. SI-BONE developed an innovative, patented implant to fuse the SI joint. The iFuse Implant System® provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90,000 procedures to date.

We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are:

• Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly.
• Creative: We embrace creativity, and we need people who are not afraid to challenge the status quo.
• Team Players: We roll-up our sleeves and work together as one team to achieve our goals.

General Responsibilities

Provide Quality Assurance and Quality Engineering support for SI-BONE products ensuring that the actions result in meeting our customer needs while maintaining compliance.
In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QMSR, ISO 13485, MDSAP 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 Regulatory and their respective management team.

Specific Responsibilities and Skills

• Manage and perform batch reviews and release product. This includes confirming SI-BONE products created by contract manufacturers meet all requirements for FDA and ISO compliance and SI-BONE quality standards prescribed by SI-BONE. This includes checking that QC testing of critical specifications, labeling of product that are compliant for both US and international products. Lead and mentor a team of QC Inspectors, overseeing review of product lot history records, inspection of RMA returns (implants, instruments, and instrument tray set) and coordination with logistics the priorities of parts to be released.
• Support Supplier Controls by maintaining the process, performing supplier audits, performing supplier evaluations and managing Supplier Corrective Action Requests.
• Manage/support ASL for Sustaining products, but may support new products as required
• Provide quality input for notified body follow up queries.
• Oversee and manage the operational aspects of ongoing projects. Monitor the project from initiation through delivery. Review status of projects and budgets; manage schedules and prepare status reports. Assess project issues and develop resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
• Partner with multiple external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance. Help create qualification strategies to implement complex changes.
• Mentor peers in the organization and help facilitate technical and professional development of others.
• Investigate product quality problems, determine root cause, gather and analyse data and implement corrective action to reduce or eliminate cause.
• Drive the CAPA/Non-Conformance process as either a CAPA/Non-Conformance owner or contributor where required for Sustaining products.
• Create quality metrics which are communicated to the organization. This includes routine review of inspection data and preparation of statistical and operational performance reports.
• Participate in investigations regarding customer complaints.
• Manage software validation projects including creation of System Requirements, Risk Assessments, the creation and execution of test protocols.
• Manage external and internal audits.
• Support the SI-BONE Quality System.
• Manage Preventive Maintenance and Calibration of Instruments/Equipment
• Manage Dose Audit Testing of Terminally Sterile Products
• Manage and implement the Radiation Safety and Protection Program for Radiation Machine such as the C-ARM. Act as the Radiation Safety Officer (RSO)
• Other duties as assigned.

Knowledge, Education and Experience

• Bachelor’s degree in an engineering or technical science
• 6+ years of directly relevant experience with a minimum of 4 years of recent experience in FDA/cGMP or other regulated environment(s)
• ASQ CQE certification preferred
• Knowledge of industry standards (FDA QMSR, ISO 13485, MDR, MDSAP)
• Experienced in Quality System requirements such as Design Control, Quality Control, Production Process Controls, Supplier Controls, Corrective and Preventive Action, and Non-Conformance.
• Knowledge of the regulatory standards and practices for human tissue processing, storage and distribution is a plus.
• Demonstrated ability to drive and deliver innovative, effective and timely solutions
• Ability to develop and implement quality programs, including tracking, analysing, reporting, and problem solving
• Expertise in the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up
• Knowledge of Software Validation a plus
• Knowledge of ERP System (QAD)
• Experience with statistical quality tools
• Excellent verbal and written communication skills
• Must be a team player

Salary range: $141,000 - $155,000. 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in SI-BONE, Inc’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.