PharmaDx Quality Engineer ( Project Manager)

Schedule:
Monday - Friday (40 hrs/wk)
8:00 AM - 5:00 PM

Department: PharmaDx Quality - 506

Primary Purpose:

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. The Quality Project Manager has in depth knowledge of medical device design control, quality management system architecture, and/or ARUP’s Product Development Program (PDP). This role may serve as a Quality Lead on project teams to implement Design Control. This position works with limited supervision and with wide latitude for independent judgment and decision making.   

About ARUP:

ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.

ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient’s life. We never forget that there is a patient behind every specimen we receive.

We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.

Essential Functions:

Uses working knowledge of applicable regulations and standards (eg. 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. 

Supports PharmaDx Quality Management in implementing strategic goals for the department. 

Represent 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. 

Other duties as assigned. 

Physical and Other Requirements:

Stooping: Bending body downward and forward by bending spine at the waist.

Reaching: Extending hand(s) and arm(s) in any direction.

Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.

Communicate: Frequently and effectively communicate with others.

PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies. 

ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.

Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.  

Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.

Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as make general observations of depth and distance.

Qualifications Education Required High School Diploma or Equivalent or better. Preferred Bachelor's Degree or better. Associates Degree or better. Experience Required 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 OR Associates degree in Medical Laboratory Science, Biology, Chemistry or related field and seven (7) years of experience in IVD, medical device, or pharmaceutical industry working under design control OR 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 Experience in companion diagnostics 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 Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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