Quality Engineer

• Provide ongoing product quality engineering support throughout the product life cycle for multiple product platforms.
• Ensure compliance with 21 CFR 820, ISO 13485, EU IVDR, cGMPs, and other applicable regulatory requirements.
• Review batch records and investigate discrepancies or anomalies.
• Perform statistical analyses on batch data and prepare statistical reports.
• Develop and implement quality control procedures.
• Participate in product release activities and provide quality assurance sign-off.
• Support quality control, field application scientists, and customer support.
• Support validation planning, transfer activities, design and development, engineering, and manufacturing.
• Support change controls, deviation management, document change management, complaints, non-conformances, and CAPA activities.
• Represent QA and QC on the incident management committee and identify quality trends.
• Assess and qualify new supplier materials.
• Drive product risk management and ensure completeness of design history files, validation packages, and change requests.
• Review verification and validation reports and identify compliance gaps.
• Coordinate issue resolution using a risk-based approach.
• Trend, analyze, and report quality data to improve products and processes.
• Provide management status updates and escalate issues in a timely manner.
• Train employees as required and maintain communication with peers.
• Travel 10%.

• Bachelor’s degree in a scientific or engineering discipline, plus a minimum 3 years of work experience in quality engineering role; or equivalent work required.
• Familiarity with regulatory requirements for IVD Products, ISO 13485, 21CFR820, IVDR, applicable experience in medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP.
• Experience in Pharmaceutical, NGS, and/or Molecular Diagnostics a plus.
• Highly organized, with ability to prioritize own tasks and ability to work effectively virtually in conducting internal and external business.
• Strong interpersonal skills.
• Excellent oral and written communication skills, including the ability to articulate clear messages from complex data/information.
• Ability to work across functions throughout a global organization at all levels.
• Ability to travel 10%.
• Follow regulatory and ISO 13485 requirements.

• Remote work schedule
• Ability to work effectively virtually
• Global organization collaboration opportunities