Job Description:
POSITION SUMMARY
The Quality Engineer supports product, process, and quality system performance within a regulated medical device manufacturing environment. This role combines hands-on manufacturing quality engineering with ownership of key Quality Management System (QMS) processes — including document change control, the calibration program, CAPA/root cause investigations, and supplier quality — while supporting internal audits and customer/supplier quality documentation.
The Quality Engineer partners closely with Production, Engineering, Supply Chain, and Quality to identify and resolve quality issues, strengthen supplier performance, reduce defects and rework, and ensure products and processes consistently meet customer, regulatory, and internal requirements. The role emphasizes proactive quality engineering — using data, structured problem solving, risk management, and process controls to prevent issues rather than relying primarily on inspection to catch them.
KEY RESPONSIBILITIES
Quality Management System & Document Control
- Own and administer the site document change control process (ISO 9001 Clause 7.5), including revision control, approval routing, distribution, and obsolescence.
- Maintain the master document list and engineering change orders (ECOs/ECNs), ensuring only current-revision documents are available at points of use.
- Coordinate cross-functional review and approval of document changes with Quality, Engineering, Production, and Supply Chain.
- Control external-origin documents (customer specs, regulatory standards, calibration certificates) and enforce record retention requirements.
Calibration & Measurement Systems
- Own and administer the site calibration program for inspection, measuring, and test equipment, ensuring equipment is calibrated within required intervals.
- Coordinate internal/external calibration activities, investigate out-of-tolerance conditions, and assess potential product impact.
- Perform or support measurement system analysis (MSA/Gauge R&R) and qualification of new inspection equipment.
Manufacturing, Nonconformance & Root Cause Analysis
- Provide day-to-day quality engineering support to manufacturing, troubleshooting product and process issues alongside Production and Engineering.
- Lead or support NCR, CAPA, and RCA investigations using structured tools (5-Why, Fishbone, 8D, fault-tree) and verify corrective action effectiveness.
- Analyze defects, nonconformances, scrap, and rework data to identify trends and drive improvements in first-pass yield.
- Monitor warranty trends and field return data to identify recurring failure modes and drive corrective actions back into manufacturing and design.
Supplier Quality Management
- Support supplier qualification, performance monitoring, and approval of new or alternate suppliers and component changes.
- Lead or support supplier corrective action requests (SCARs), including root cause review and effectiveness verification.
- Analyze incoming inspection and supplier quality data to identify risks and establish risk-based supplier controls.
Audits & Customer Quality Documentation
- Participate as an internal auditor; support planning, execution, and follow-up of internal audits and audit readiness.
- Support customer, registrar, and regulatory audits, including ISO 9001/ISO 13485 certification audits.
- Coordinate and complete supplier and customer quality questionnaires and compliance documentation.
- Support investigation of customer complaints and field quality issues, feeding lessons learned back into manufacturing.
QUALIFICATIONS
Required
- Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical field (or equivalent experience).
- 3+ years of quality engineering experience in a regulated or highly controlled manufacturing environment.
- Experience within a formal QMS, including document/change control and calibration/measurement equipment control.
- Demonstrated root cause analysis and CAPA experience, and familiarity with nonconformance and risk management processes.
- Strong analytical, organizational, and communication skills; ability to interpret drawings, specifications, and technical requirements.
Preferred
- Experience in medical device manufacturing; working knowledge of ISO 13485, FDA QSR (21 CFR 820), and ISO 14971.
- Experience with SPC, Cpk/Ppk analysis, MSA/Gauge R&R, PFMEA/DFMEA, and process validation (IQ/OQ/PQ).
- Experience with supplier qualification, SCARs, and customer/supplier quality questionnaires.
- Familiarity with QMS/ERP software (e.g., MasterControl, ETQ, M1, Infor LN) and statistical software (e.g., Minitab).
- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification.
PHYSICAL / WORK ENVIRONMENT
- Manufacturing floor and office environment; PPE required on the production floor.
- Occasional travel for supplier audits, as applicable.
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Company:
Machine Solutions, Inc.
