Quality Assurance - Logan, Utah, United States

The Quality Assurance Manager will serve as the QA representative at a newly acquired location, working under the direct authority and oversight of the Business Unit QA Director (Logan, Utah). This role supports both the integration of the site into the business unit's electronic ...

Job description

The Quality Assurance Manager will serve as the QA representative at a newly acquired location, working under the direct authority and oversight of the Business Unit QA Director (Logan, Utah). This role supports both the integration of the site into the business unit's electronic Quality Management System (eQMS), ERP (SAP), and the ongoing quality operations after integration is complete. The position is hands-on and will support daily QA activities, manufacturing and operations quality, QC support (as assigned), SAP data quality and alignment, training and documentation control, post-market quality activities, and new product introduction (NPI).

Essential Duties and Responsibilities

• QMS Integration: Support the alignment and migration of site quality documents into the business unit's eQMS. Perform review of SOPs, WIs, and records and route through approval. Assist with identifying QMS gaps and escalating them appropriately. Help train site personnel on QMS procedures, documentation standards, and compliance requirements.
• Ongoing Quality Assurance Support: Provide daily QA support to manufacturing, QC, engineering, operations, and supply chain. Review production batch records, device history records, equipment files, deviations, supplier files, nonconformances, and change controls. Maintain controlled documentation, training records, and quality logs in the eQMS. Support internal audits and inspection readiness activities. Serve as the QA liaison for external audits, escalations, decisions, and approvals.
• QC Support (As Assigned / Based on Site Need): Assist with QC documentation review, test method alignment, sample handling, or records support. Partner with teams to ensure procedures and records meet QMS expectations. Help coordinate equipment verification, calibration tracking, or QC data integrity tasks if required. Note: Level of QC involvement may expand based on site structure.
• Data & System Compliance (SAP + eQMS): Support Operations in preparing quality-related data for SAP, including materials, BOMs, routings, and specifications. Conduct QA checks on SAP records for completeness and alignment with controlled documentation. Support BU QA validation of SAP data during integration and future changes. Serve as the QA point of contact for SAP-related data quality tasks.
• Post-Market Quality Support: Assist in collecting, verifying, and documenting information for complaints, nonconformances, and CAPAs. Provide onsite support for failure investigations and data gathering. Participate in trend analysis and product performance monitoring.
• New Product Introduction (NPI): Support quality deliverables for new or transferred products introduced at the site. Participate in risk assessments, validation activities, and readiness reviews. Support documentation, training, and process preparation for NPI.
• Training & Site Communication: Provide support for QMS training implementation and competency tracking. Act as the primary communication bridge between the site and the Business Unit QA Director. Participate in ongoing training from BU QA to gradually increase expertise and independence.
• Assists with related special projects, as required.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required:

• 3+ years of experience in Quality Assurance in a regulated industry (medical device, IVD, biotech, or similar) in QA/RA Management, Quality Engineering, or Product/Project Management roles.
• Experience with an electronic QMS (eQMS).
• Experience with SAP or other ERP systems.
• Working knowledge of ISO 13485, FDA QMSR.
• Strong documentation and record-review experience.
• Excellent communication and collaboration skills.

Preferred Qualifications

• Experience supporting QC or analytical/laboratory quality activities.
• Exposure to cleanroom, manufacturing QA, or equipment qualification.
• Experience with post-market quality processes (CAPA, nonconformance, complaint support).
• Experience supporting new product introduction or validation activities.
• Prior involvement in quality system integrations or multi-site harmonization.
• Experience with Regulatory Affairs activities or exposure to RA processes.
• IVDR and MDSAP experience highly preferred.
• Ability and skills in the use of advanced personal computer productivity programs for word processing, spreadsheets, database manipulation and flow
• This position interfaces with all levels of the organization, management and staff, and with customers and suppliers; confidentiality is important to this job