Design Quality Engineer

Shoolin Inc; Minnesota; On-site; USD 90,000 - 120,000; Full time

Job summary

Shoolin Inc is seeking a Design Quality Engineer to support product development, design controls, and regulatory compliance in a highly regulated environment.

You will drive risk management, V&V, DHF maintenance, CAPA and change control, partner with R&D, Regulatory Affairs and QA, and ensure alignment with FDA/ISO requirements throughout design, verification, validation, and product transfer.

Qualifications

• Bachelor's degree in engineering or life sciences or related field.
• 3+ years of Design Quality / Quality Engineering in a regulated industry.
• Experience with medical devices, pharmaceuticals, biotechnology or life sciences.
• Strong knowledge of Design Controls and Risk Management.
• Experience with V&V, DV&V, CAPA, NCR/nonconformance, and change control.
• Experience in regulated Quality Management Systems (QMS).
• Familiarity with FDA and ISO requirements.

Responsibilities

• Support design and development projects from concept through launch.
• Implement and maintain Design Control processes per requirements.
• Review and approve documentation: design inputs/outputs, design reviews, DV/DV&V.
• Develop DFMEA, risk assessments, and risk management files.
• Participate in root cause analysis, CAPA, nonconformance investigations.
• Support engineering change control and assess regulatory impact.
• Collaborate with R&D, Manufacturing, Regulatory, and QA teams.
• Ensure compliance with FDA/ISO quality requirements and audits.

Skills

Design Controls

Risk Management

CAPA

NCR/Nonconformance

V&V

DV&V

QMS

FDA/ISO requirements

Audits/Inspections

Technical writing

Problem solving

Education

Bachelor's degree in Engineering, Life Sciences, Biology, Chemistry, Pharmacy, or related field

Tools

TrackWise

Veeva

ETQ

MasterControl

eQMS

Job description

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.

Key Responsibilities

• 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.
• Participate in root cause analysis, CAPA, nonconformance, deviation, and complaint investigations.
• 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.
• 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.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biology, Chemistry, Pharmacy, or a related technical field.
• 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.
• Experience with V&V / DV&V activities.
• Knowledge of CAPA, NCR/Nonconformance, Change Control, and Root Cause Analysis.
• Experience working within regulated Quality Management Systems (QMS).
• Strong understanding of FDA and ISO requirements.

Preferred Skills

• Experience with 21 CFR Part 820 / QMSR.
• Knowledge of ISO 13485 and/or ISO 14971.
• 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 TrackWise, Veeva, ETQ, MasterControl, 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.
• Strong technical writing, documentation, communication, and problem-solving skills.