PharmaDx Quality Engineer ( Project Manager)

About the role

The PharmaDx Quality Project Manager supports the maintenance of the PharmaDx Quality Management System (QMS) to ensure compliance with applicable regulations (e.g., GMPs, GCPs). The Quality Project Manager may maintain the internal and external audit schedules, host audits and regulatory inspections, and approve audit reports.

Responsibilities

• Uses working knowledge of applicable regulations and standards (e.g. ISO:13485, FDA CFR820, IVDR, CAP/CLIA, GMP, PMDA, ROW standards, etc) to contribute to the development and approval of companion diagnostic tests, management of clinical trials and compliance with PharmaDx QMS.
• Possesses a strong working knowledge of medical device design control and/or change control.
• Authors, reviews, and/or approves applicable PharmaDx policies and procedures in support of the QMS to ensure compliance with ISO 13485, FDA 21CFR 820, EU IVDR, and other regulatory requirements.
• Performs Quality review of design control, risk management, and post market documentation as needed to ensure documents meet ARUP policies.
• Supports nonconforming product and CAPA investigations. This may include leading the investigation, participating in root cause analysis, or implementing corrective/preventive actions.
• Prepares and participates in audits or inspections from sponsors and/or regulatory authorities and manages the preparation of audit responses.
• Manages the external supplier audits and internal audit schedules and ensures audits are executed in compliance with PharmaDx SOPs.
• Serves as a Quality Lead on project teams to implement Design Control.
• Represents the PharmaDx team in the change control process.
• Supports the generation of Management Review data/metrics.
• Creates new processes and procedures, as applicable.
• Mentors other Quality staff as applicable or assigned.

Qualifications

• Required: Associates Degree or better in Medical Laboratory Sciences. Bachelor's Degree or better in Medical Laboratory Sciences. High School Diploma or Equivalent or better.
• Experience: Bachelor’s degree in Medical Laboratory Science, Biology, Chemistry or related field and four (4) years of experience in IVD, medical device, or pharmaceutical industry working under design control. Associates degree in Medical Laboratory Science, Biology, Chemistry or relatied field and seven (7) years of experience in IVD, medical device, or pharmaceutical industry working under design control. High School diploma and ten (10) years of experience in IVD, medical device or pharmaceutical industry working under design control.
• Preferred: American Society for Quality (ASQ) Certification in Six Sigma, Auditing or similar discipline. Four (4) years of experience in Quality Assurance or other applicable industry experience. Intermediate to advanced experience with Microsoft Word, Excel, and PowerPoint. Experience with statistical analysis (e.g. Sampling Plans, SPC). Demonstrated strong organizational, problem solving, troubleshooting, and interpersonal skills. Experience working in a GMP (Good Manufacturing Practices) compliant environment. Excellent written and oral communication skills.