Job Details

Target Pay Range: 43.50-54.25/hr DOE

Responsibilities

• Manage the document control program and identify, recommend, and implement process improvements.
• Analyze, process, and track Change Requests (CRs) and Change Orders (COs) in Ensur.
• Write, edit, review, and maintain controlled documentation, including WIs, policies, procedures, and change management records for Laboratory Services (ILS).
• Perform document control activities, including document processing, distribution of controlled copies, and filing using manual and electronic systems in accordance with established procedures.
• Monitor change activity approvals and implementations; proactively identify and resolve issues of varying complexity.
• Facilitate records management activities, including retention and archival, ensuring compliance with applicable regulations.
• Maintain personnel records within the quality system.
• Assign document-related training based on management requests and departmental training matrices and plans.
• Create, maintain, and update organizational training matrices in collaboration with management.
• Track, trend, and report on document-related training compliance.
• Communicate and deliver training to users as required.
• Manage or support the training program and continuously improve training processes.
• Support competency assessment tracking and periodic training records review.
• Collaborate cross-functionally and with other sites and external partners to implement new processes and promote awareness of quality policies and procedures.
• Monitor quality system process metrics and develop or support corrective action plans as needed.
• Identify opportunities for business process improvement through analysis, tracking, and trending of quality inputs and review data.
• Provide management with regular status updates on assigned responsibilities and escalate risks or issues in a timely manner.
• Support supplier management activities.
• Provide PDP (Product Development Process) support and drive PDP continuous improvement initiatives.
• Support research collaboration studies.
• Perform miscellaneous quality system tasks, including Work Instruction (WI) reviews and change management reviews.
• Perform other duties as assigned by management.

All listed tasks and responsibilities are considered essential functions of the position. Business conditions may require reasonable accommodations or assignment of additional responsibilities.

Requirements

• Quality certification preferred (e.g., CQE, CQA).
• Minimum of 5 years of experience in a Quality Assurance role within a regulated environment; direct experience in in-vitro diagnostic (IVD) manufacturing strongly preferred.
• Demonstrated experience applying quality regulations and standards, including:
  • 21 CFR Part 820
  • ISO 13485
  • ISO 14971
  • CLIA, CAP, CLEP
• Practical experience in process improvement, risk management, validation, change control, and supplier quality.
• Strong organizational and task management skills, with the ability to manage multiple priorities effectively.
• Experience using quality and statistical analysis tools, including SPC, risk analysis, FMEA, DOE, and trend analysis.
• Excellent interpersonal, written, and verbal communication skills.
• High attention to detail; well-organized and capable of working independently and in cross-functional teams.
• Strong critical thinking and problem-solving abilities.
• Proven ability to achieve goals while collaborating across departments in fast-paced corporate environments.
• Demonstrated experience working with complex Quality Management Systems (QMS) and ERP platforms (e.g., SAP, EtQ).
• Advanced proficiency in Microsoft Word and Excel; experience with tools such as LucidChart to perform data analysis, trend reporting, and development of process maps and procedures.