Manager, Quality Assurance

Job Description

Lead, support and coordinate efforts that foster quality and ensure that all pre-analytical, analytical and post-analytical processes for FDA-ready submissions for Haystack Oncology are consistent with our company values and mission. 

This is an Onsite position.

 Work schedule: Hybrid (3 days Onsite/ 2 days work from Home)

1) Design Control & Risk Management 

• Ensure all IVD development activities comply with FDA 21 CFR Part 820 and ISO 13485 
• Participate and contribute to Design inputs/outputs reviews, verification and validation planning, Design transfer, and Design history file compilation.
• Lead or contribute to hazard analysis and risk assessment using ISO 14971

2) Validation Testing and Documentation 

• Ensure documentation is complete, reviewable, and audit ready.
• Collaborate with Document Control to ensure controlled documents (SOPs, test records, validation packages) are managed appropriately.
• Ensure all documents are compliant with company policy, regulation requirements, and standards. 
• Maintain hard copy records in accordance with Quest’s retention policy.
• Create standard templates for validation and testing deliverables.
• Author and revise procedures and work instructions related to validation lifecycle, change control, and risk management.

3) Leadership  

• Direct, advocate for and enable visibility of quality processes.  
• Ensure accountability within all areas of the business unit (pre-analytical, analytical and post-analytical) such that every employee consistently exhibits behavior that promotes and supports quality. 
• Influence may be exerted both directly and indirectly through the management of liaisons and intermediaries, such as department managers and supervisors as well as members of the Quality Assurance (QA) Committee.   

4) Quality Assurance/Quality Improvement  

• Conduct monthly QA meetings with required participation by all areas (including RRLs and Metro Laboratories) having an impact on pre-analytical, analytical and post-analytical phases of testing (exception Billing).  
• Create effective materials (e. g., graphs, charts) to promote Quality Improvement (QI) and present plans and results at monthly meetings.  
• Develop, monitor and improve Quality Assurance specific quality indicators, including but not limited to: Reportable Quality Issues, Proficiency Testing outcomes, Revised Reports tracking, and performance on inspections.  
• Prepare, revise and distribute a QA Manual that includes local QA policies. Ensure all applicable employees are trained and comply with policies.  
• Ensure all QA policies have annual review.  
• Ensure a process is in place to resolve customer complaints regarding pre-analytical, analytical, and post- analytical issues.  
• Ensure performance of required Corporate Quality Surveillance Program, Patient Results Distribution Program, Best Practice Team Initiative/Database Changes Verification Program and other monitoring programs specifically assigned by National Quality Assurance (NQA).  
• Ensure enrollment and participation in external federal and state cytology proficiency testing as well as required educational programs.  

4) Quality Control  

• Act as a contact for FDA QA audits and other national Quality Control (QC) peer comparison programs and ensure enrollment and effective corrective action as appropriate.  

5) Quality Assurance Initiatives  

• Ensure all duties are appropriately delegated as required by applicable federal, state and local regulations.  
• Ensure that all departments have a process to identify and evaluate the relationship of patient information to patient test results.  
• Ensure the process is in place, up to date, distributed and that all personnel are in compliance.  
• Ensure prompt and complete reporting. 

Required Work Experience:  

• 5+ years of experience in in medical device and/or IVD industry. 
• Hands-on experience with authoring, review, and root-cause analysis of validation deliverables.
• Lead experience on validation projects and ownership of full validation lifecycle.
• Demonstrated Experience applying Medical device regulations (e.g.IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, ISO 15189, IVDR, CAP, and CLIA). 

Preferred Work Experience:  

• Experience with EU MDR/IVDR and international regulatory submissions
• Experience with eQMS systems such as MasterControl, Trackwise, or Veeva

Physical and Mental Requirements:  

• Strong attention to detail for thorough documentation to ensure consistency in documentation. 
• Excellent problem-solving skills to identify and address quality issues effectively. 
• Ability to manage multiple work projects to meet deadlines while maintaining accuracy. 
• Must be able to occasionally move and lift objects of up to 25 pounds. 

Knowledge:  

• Strong working knowledge of applicable regulations, such as but not limited to, the medical device regulations: FDA 21 CFR Part 820 Quality Systems Regulations/new Quality Management System Regulation and ISO 13485 standards. Preferred: ISO 14971, ISO 15189, IVDR, CAP, CLIA, and NYSDOH requirements. 

Skills:  

• Applying risk-based validation based on ISO 14071 and GAMP principles to prioritize validation efforts. 
• Ability to work independently and collaboratively with cross-functional departments in a fast-paced environment with minimal supervision. 
• Proficient in document management systems.