What are the responsibilities and job description for the Quality Engineer position at Comrise?
12 months contract to extension
• On site 4 days/week, 1 remote day
• Typical hours: 7:30 AM–5/6 PM
Key Areas of Responsibility:
• Work closely with Operations and the business functions to ensure quality performance of product and processes.
• Non-Conformances
o Collaborate with Internal cross-functional and Supplier teams to address top quality issues.
o Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise.
o Support execution and analysis of manufacturing related complaint investigations and product field actions.
o Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.
• Supplier Activities
o Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.
o Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval
o Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
o Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
• Process Improvements/Validation
o Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.
o Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.
o Participate in and potentially lead the creation and/or review of new or modified procedures.
o Support the development and review of process and equipment validation/qualification and MSA of internal processes.
o Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
Preferred (Not Required) Background
• Medical device experience (preferred, not required)
• Experience in a regulated industry
• Engineering or science degree (BS preferred) Example of a successful prior hire:
• Background in bioscience/lab work • No direct manufacturing experience initially
• Strong technical thinking, stakeholder management, and execution speed
• Successfully translated lab skills into manufacturing quality work
Tools & Systems Used
• TrackWise – nonconformances, CAPAs, complaints
• MasterControl – document management
• SAP – order management, holds, manufacturing systems (SAP experience helpful but trainable)
Quality Tools & Concepts They Like to See
• PPAP (nice to have)
• Validation experience
• DFMEA / PFMEA
• Control Plans
• Process Flow Diagrams
• Ability to define requirements and collect objective evidence
Salary : $52 - $57