Design Quality Engineer

We are seeking an experienced Design Quality Engineer to support product development, design controls, quality engineering, and regulatory compliance activities within a highly regulated Medical Device, Pharmaceutical, Biotechnology, or Life Sciences environment.

The ideal candidate will have hands-on experience working with Design Controls, Risk Management, CAPA, Change Control, Verification & Validation (V&V), Design History Files (DHF), and quality systems
. Candidates with experience supporting regulated products from concept through commercialization are strongly preferred.

• Support design and development projects from concept through product launch and sustaining engineering.
• Implement and maintain Design Control processes in accordance with applicable quality and regulatory requirements.
• Review and approve engineering and quality documentation, including:
• Design Inputs and Design Outputs
• Design Reviews
• Verification and Validation protocols/reports
• Change Requests
• Specifications and drawings
• Support Design Verification and Design Validation (DV/DV&V) activities.
• Develop and maintain Design FMEA (DFMEA), risk assessments, and risk management files
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• Participate in root cause analysis, CAPA, nonconformance, deviation, and complaint investigations
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• Support engineering change control and assess quality/regulatory impact of product and process changes.
• Partner with R&D, Manufacturing Engineering, Regulatory Affairs, Clinical, Operations, and Supplier Quality teams.
• Ensure product development activities comply with applicable FDA, ISO, GMP, and company quality requirements
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• Support audits and inspections by internal and external regulatory bodies.
• Maintain and update quality records within electronic Quality Management Systems (eQMS).
• Provide quality input during new product introduction (NPI), process development, and product transfer activities.
• Identify potential quality risks and drive continuous improvement initiatives.

• Bachelor's degree in Engineering, Life Sciences, Biology, Chemistry, Pharmacy, or a related technical field
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• 3+ years of Design Quality / Quality Engineering experience in a regulated industry.
• Background in one or more of the following:
• Medical Devices
• Pharmaceuticals
• Biotechnology
• Life Sciences
• Strong understanding of Design Controls and Risk Management
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• Experience with V&V / DV&V activities.
• Knowledge of CAPA, NCR/Nonconformance, Change Control, and Root Cause Analysis
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• Experience working within regulated Quality Management Systems (QMS).
• Strong understanding of FDA and ISO requirements
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• Experience with 21 CFR Part 820 / QMSR
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• Knowledge of ISO 13485 and/or ISO 14971
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• Experience with GMP/cGMP environments.
• Experience with Design History Files (DHF) and Device Master Records (DMR).
• Experience with FMEA, Risk Management, and Fault Tree Analysis (FTA).
• Experience with electronic QMS systems such as Track Wise, Veeva, ETQ, Master Control, or similar.
• Familiarity with Agile PLM, Windchill, Arena, or other PLM systems is a plus.
• Experience supporting FDA audits, notified-body audits, or other regulatory inspections
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• Strong technical writing, documentation, communication, and problem-solving skills.