Quality Assurance Engineer

POSITION TITLE:
Quality Assurance Engineer

SCOPE:
The role provides Quality Engineering support in the execution of manufacturing and risk management deliverables associated with new and existing products to meet global medical device regulations. The role also provides Quality Engineering support to complaint handling, design controls, and supplier-related activities associated with new and existing products.

PRIMARY RESPONSIBILITIES:

• Serve as Quality Engineering representative ensuring that design and manufacturing related activities are completed and comply with global medical device regulations (e.g., FDA, EU, etc.) and internal Quality System requirements.
• Conduct risk assessments and implement risk management strategies to address potential quality issues throughout the product lifecycle.
• Support root cause analysis and corrective action processes for non-conformities, including the development and implementation of preventative measures.
• Generate and ensure compliant completion of Quality deliverables, including change requests, risk management deliverables, test methods, process validation, packaging and labeling documentation, SOPs, and manufacturing work instructions. Ensure all documentation is accurate and up to date.
• Assist with internal and external audits to assess the effectiveness of the quality management system and ensure compliance with regulatory and company standards.
• Provide key quality trending information and data for use in periodic reviews.
• Investigate customer complaints and analyze feedback to identify trends and drive improvements to product quality and customer satisfaction.
• Evaluate and monitor suppliers for quality performance. Collaborate with suppliers to address and resolve quality issues.
• Be flexible and work within a small team without strictly defined roles to assure complete functional coverage.

EDUCATIONAL PREREQUISITES AND SKILL REQUIREMENTS:

• BS in STEM (Science, Technology, Engineering, Mathematics).
• 3–5 years of Quality Engineering experience in the medical devices or pharmaceutical industry with demonstrated competency of 21 CFR 820, EU MDR, EN ISO 13485, and EN ISO 14971.
• Strong communication and presentation skills; energetic, proactive, and flexible with high integrity and ethics in all dealings.
• Competent in Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent).
• Ability to prioritize, focus, collaborate, and work effectively in a fast-paced and dynamic cross-functional environment.

TRAINING REQUIREMENTS:

• Undergo all formal Training Events as directed.
• Observe and comply with all Corporate Policies.
• Work within, and ensure adherence to Quality System procedures, work instructions, and other Quality System requirements.
• Work within, and ensure adherence to Health, Safety and Environment Management System procedures, instructions, and other requirements.

Target Pay Rate Range: $40-50/hr depending on experience