Quality Engineer

The Quality Engineer is responsible for providing ongoing product quality engineering support throughout the product life cycle for multiple product platforms.  The individual is responsible for ensuring compliance to 21 CFR 820, ISO 13485, EU IVDR and other applicable international / local regulatory requirements.

What You’ll Be Doing

• Conduct comprehensive reviews of batch records to ensure compliance with cGMPs and company procedures.
• Identify and investigate potential discrepancies or anomalies in batch records.
• Perform statistical analyses on batch data to assess product quality and identify trends.
• Prepare and maintain statistical reports to document findings and support quality decision-making.
• Contribute to the development and implementation of quality control procedures.
• Participate in product release activities, including reviewing release documentation and providing quality assurance sign-off.
• Stay up-to-date on the latest cGMP regulations and quality engineering practices.
• Provide quality support to quality control, field application scientists, and customer support
• Provide support to design and development, engineering, and manufacturing for functions for validation planning and transfer activities.
• Collaborates with Quality Management to support change controls activities (e.g. engineering, process, raw materials, etc.) deviation management, and document change management.
• Ensures adequacy of complaint, non-conformances and CAPA records, investigations, and corrective/preventive actions.
• Represents QA and QC on the incident management committee in efficiently processing customer incident and identifying trends to help improve product quality.
• Provides quality support in the assessment and qualification of new supplier materials such as component specifications and inspection standards.
• Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change requests.
• Provide quality consultation to end users and process owners with regards to data collection, analysis, and creation of validation reports.
• Become familiar with the applicable technology to facility ate participation in technical discussions and risk-based decision making.
• Review verification and validation reports and identify gaps for compliance to internal quality requirements.
• Coordinate issue resolution using risk-based approach.
• Identify areas and opportunities to improve quality system processes and product issues.
• Ensure product development and validation programs meet internal quality programs.
• Trend, analyze, and report on quality data in order to improve product and processes.
• Provide management with status updates on assigned responsibilities and goals.
• Escalate issues in a timely fashion.
• Own and/or coordinate CAPAs, Complaints, and NCRs specific to product quality issues.
• Effectively influences and trains employees (as required).
• Maintains strong communication network with peers.
• Demonstrated effective knowledge of use of various computer systems.
• Additional responsibilities as assigned.
• Ability to travel 10%
• Follow regulatory and ISO 13485 requirements

What You’ll Bring to the Team

• 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.