Supplier Quality Specialist III (Contractor) at Freenome

<p><strong>About this opportunity:</strong><strong><br></strong></p> <p><span style="font-weight: 300;">The Supplier Quality Specialist III/IV plays an integral role in supporting quality activities related to Supplier Management in accordance with FDA, ISO, and other IVD regulations. This individual also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation 21 CFR § 820 and ISO 13485 as well as CLIA, CAP, and applicable state requirements. In this role you will facilitate the supplier compliance program (external audits, drive improvement in supplier performance, supplier development, supplier selection and qualification). In addition, this role will support the quality assurance activities in partner development as needed.&nbsp;</span></p> <p><strong>What you’ll do:</strong></p> <ul> <li style="font-weight: 300;"><span style="font-weight: 300;">Maintain the approved supplier list and supplier audit schedule</span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Drive compliance with applicable quality management system requirements, engaging in supplier corrective actions as needed</span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Conduct external and internal quality audits to identify potential areas of risks and drive continuous improvement<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Lead establishing quality agreements with critical suppliers, and quality of supplier records<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Actively participate in supplier quality related communication and feedback.<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Lead the processing of supplier change notifications&nbsp;<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Engage directly with Freenome suppliers to drive quality and process improvements in order to continuously improve the quality of product and services received<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Maintain supplier non-conformances to closure and effectiveness review, working with impacted departments<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Maintain organized records that demonstrate compliance to all company processes, regulations, and the company’s QMS<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Support routine Quality processes such as document control, employee training, investigating non-conformances, quality metrics, etc.</span></li> </ul> <p><strong>Must haves:</strong></p> <ul> <li style="font-weight: 300;"><span style="font-weight: 300;">Minimum of a Bachelor's degree in a life science field (genetics or molecular biology preferred) or equivalent experience<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">5+ years of experience in manufacturing operations, clinical laboratory operations, quality, or supplier quality<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">ISO 13485 certified Lead Auditor or Certified Quality Auditor (CQA)<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Effective problem solving skills and ability to identify, analyze and solve problems with minimal direction and escalate concerns to management<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Proficiency in Word, Excel, PowerPoint or Google Workspace and experience with document management systems and document sharing systems<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Ability to prioritize and multitask while maintaining a positive and collaborative attitude<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Experience with both internal audits or external audits<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Flexibility to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Drive for results and continual improvement<br></span></li> <li style="font-weight: 300;"><span style="font-weight: 300;">Travel 10 - 30% domestically and potentially internationally, potentially more as needed<br></span></li> </ul> <p><strong>Nice to haves:</strong></p> <ul> <li><span style="font-weight: 300;">Certified Quality Engineer, CQE (ASQ)</span></li> <li><span style="font-weight: 300;">Experience in quality system methodologies including but not limited to CAPA, Lean, 5 Why's, Pareto Analysis, Six Sigma</span></li> <li><span style="font-weight: 300;">Experience with statistical process control (SPC) techniques to evaluate and improve process performance</span></li> <li><span style="font-weight: 300;">Experience with process validations<br></span></li> </ul> <p><strong>Additional information:</strong></p> <p><span style="font-weight: 300;">Contractors may be hired through a third-party provider and will be considered contingent workers. </span><span style="font-weight: 300;">We invite you to check out our career page @ <em><a href="http://freenome.com/job-openings/" target="_blank" data-saferedirecturl="https://www.google.com/url?q=http://freenome.com/job-openings/&amp;source=gmail&amp;ust=1708620295766000&amp;usg=AOvVaw0K-a4lTJ0RquYagpqS-yp4">freenome.com/job-openings/</a></em> </span><span style="font-weight: 300;">for additional company information.&nbsp;&nbsp;</span></p> <p><span style="font-weight: 300;">Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local </span><span style="font-weight: 300;">law.</span></p> <p><em><span style="font-weight: 300;">Applicants have rights under Federal Employment Laws.&nbsp;&nbsp;</span></em></p> <ul> <li><span style="font-weight: 300;"><em><a href="https://www.dol.gov/agencies/whd/posters/fmla" target="_blank"><em><span style="font-weight: 300;">Family &amp; Medical Leave Act (FMLA)</span></em></a></em></span></li> <li><span style="font-weight: 300;"><em><a href="https://www.dol.gov/agencies/ofccp/posters" target="_blank"><em><span style="font-weight: 300;">Equal Employment Opportunity (EEO)</span></em></a></em></span></li> <li><span style="font-weight: 300;"><em><a href="https://www.dol.gov/agencies/whd/posters/employee-polygraph-protection-act" target="_blank"><em><span style="font-weight: 300;">Employee Polygraph Protection Act (EPPA)</span></em></a></em></span></li> </ul> <p><span style="color: #ecf0f1;"><em><span style="font-weight: 300;">#LI-HYBRID</span></em></span></p>