Senior Quality Control Inspector

The Senior Quality Inspector is a core team member of the Quality department. Performs inspection of incoming products, reviews supplier inspection data, and lot history records.  This role is a trusted partner to other departments and builds strong relationships both internally and externally. This position must demonstrate abilities to work cross-functionally throughout the company with excellent communication skills. A motivated self- starter and attention to detail is key to the core role of Senior Quality Inspector, ensuring that all process are followed per procedures. The role will also strive for continuous process improvement.

This role is responsible for performing all duties in compliance with FDA’s Quality System Regulations, ISO 13485, MDD, MDR and all applicable worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual.

 The employee must at all times act and conduct company business in an honest, ethical and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code and all applicable laws and regulations, whether national, regional, state or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

• Conduct inspection of incoming, reworked, and returned products
• Review LHRs, supplier data, and other related documentation
• Conduct/perform first article inspection reports
• Initiate non-conformance reports and support investigation, review, and closure
• Help train, support, and guide other quality control inspectors
• Scan and archive quality records
• Initiate deviations and support investigation, review, and closure
• Help track tasks and due dates for deviations, NMRs, SCARs, CAPAs, and IACAs
• Contact supplier for quality related issues and related documentation
• Create/update metrics and conduct trending of incoming parts and product releases
• Create NMR and inspection related metrics and slides for Management Review as required
• Participate in internal and external audits, gather documentation and help respond to inquiries
• Support Document Control activities
• Support improvement projects 
• Perform tasks accurately, with compliance to internal procedures, and in a timely manner
• Note that the job description is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time as dictated by business needs.
• 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 and/or Regulatory and his respective management team.

• Bachelor’s degree or equivalent experience is required.
• At least 8 years of progressive experience in medical device or related industries
• Working knowledge of GMPs and their application to medical devices
• Good  oral and written communication skills with the ability to work effectively with others
• Highly organized, strong attention to detail
• Outgoing, self-starter with the ability to work in a high paced team environment, meet deadlines, and independently prioritize workload
• Computer proficiency in Microsoft Office and other software used by the business (e.g., DocuSign, eQMS, ERP)