ENGINEERING QUALITY MANAGER Full-Time Monday-Friday Benefits: Medical (UHC), Dental, Vision, Critical Illness, Short Term Disability, Life Insurance, 401k w/company match, paid holidays and PTO. Position Overview: The Engineering Quality Manager collaborates with the engineering team, supporting both New Product Development and ongoing manufacturing activities for medical devices. This professional collaborates closely with Engineering, Production and Operations to ensure that all products and processes meet applicable ISO 13485, ISO 9001, and 21 CFR 820 quality and regulatory requirements. This role combines hands-on process verification and SPC activities with strategic improvement initiatives – ensuring design-transfer integrity, robust process capability, and sustainable quality controls. The position requires a self-motivated individual who can work independently while effectively partnering across departments. It is expected that this role will evolve into a broader Quality Management position, providing leadership continuity as the current Quality Manager advances within the organization. Essential Job Functions: - Partner with Engineering on New Product Development projects to ensure quality is embedded throughout the design and development lifecycle.
- Develop and maintain NPI quality documentation, including Process Flow Diagrams, PFMEAs, Control Plans, and Validation Protocols (IQ/OQ/PQ).
- Perform and document process verifications, first article inspections, and SPC studies to establish baseline process capability and identify improvement opportunities.
- Participate in design transfer and process validation activities to confirm that production processes consistently meet product requirements.
- Analyze quality data, process trends, and CPK results to support data-driven decisions and corrective/preventive actions (CAPA).
- Lead or support root cause analyses, nonconformance investigations, and risk management updates.
- Update and maintain Methods of Manufacture (MOMs), tool and equipment documentation, and change notices as part of the document-control process.
- Drive the creation and revision of SOPs, work instructions, and control procedures aligned with current best practices and regulatory expectations.
- Train and mentor employees in quality control principles, process capability, and regulatory compliance to strengthen organizational quality culture.
- Work independently to identify improvement opportunities, propose and implement corrective actions, and introduce new or refined controls that enhance product and process quality.
- Support internal and external audits, supplier evaluations, and management reviews as required.
Required Qualifications: - Experience in Quality Engineering, Quality Assurance, or Manufacturing Quality within the medical-device or regulated manufacturing industry.
- Strong working knowledge of ISO 13485, 21 CFR 820, and ISO 9001 Quality Management Systems.
- Hands-on experience with Statistical Process Control, process verification/validation, root cause analysis, and CAPA systems.
- Proficiency in developing and maintaining PFMEA, Control Plans, and validation protocols.
- Demonstrated ability to lead cross-functional teams, communicate effectively, work independently, and drive sustainable improvements.
- Exceptional attention to detail and organizational discipline in managing documentation and data.
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