The Senior Quality Engineer is an advanced level position that works with cross-functional teams to ensure product and processes meet specifications and operate within claims and control parameters in alignment with Quality Management Systems (QMS) requirements. This position works with Regulatory Affairs, R&D, Quality Assurance, contract suppliers, and/or Manufacturing using technical knowledge and expertise to execute regulatory and business objectives.
- Product and Process Life Cycle : Represent Quality Engineering in Design and Development activities through launch, product and process Changes, sustaining on-Market safety and efficacy, and post-market surveillance endeavors. Provide subject matter expertise and ensure the delivery of objective evidence using scientific methodology including technical validity, accuracy, complete, and compliance to applicable regulations and standards in QMS areas such as product and process development, specification development, acceptance methods development, design transfer, design validation, process validation, risk management, product realization, packaging and shipping validation, product launch, and non-conformance assessment.
- Risk Management : Maintain QMS procedures that facilitate risk management activities and produce audit ready risk file documents in compliance with the requirements of current international risk management standards and regulations.
- Quality Science and Engineering: Perform independent quality review and evaluation of change orders including related data for scientific approach, presence of supporting objective evidence, technical validity, accuracy, completeness, and compliance to applicable regulations and standards. Provide guidance on identified gaps and collaborates to determine remediation activities. Apply critical analytical thinking in the investigation process specifically during root cause analysis, risk assessment evaluation and determination corrective and preventive actions determination to guarantee gaps are properly addressed. Provide Quality input into process investigations using a systematic approach to ensure root causes and CAPAs are aligned. Collect and analyze defined quality metrics, quality-related data to identify issues or trends.
- Quality Management Systems : Identify applicable processes for new standards and regulations. Ensure departmental records, QMS procedures, and controlled documents comply with applicable regulations and standards. Aid in designing and documenting new and revised quality systems for product realization compliance with applicable regulations and standards. Ensure QMS processes, procedures, and quality documentation to maintain a state of audit readiness. Escalate events that may contribute negatively to medical devices safety or efficacy. Address and remediate events that may contribute negatively to QMS processes or effectiveness. Apply critical analytical thinking in the investigations and nonconformance systems specifically during root cause analysis, risk assessment evaluation, and corrective and preventive actions determination to guarantee that (potential and actual) non-conformances are properly addressed. Support other functions in resolving on quality systems issues and concerns.
- Support internal, and third-party audits, regulatory inspection preparation and execution. Assist in closing audit findings by providing quality guidance for investigations, and implementation of resulting corrections, and/or corrective actions/preventative actions.
- Ensure compliance with applicable standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies.
- Bachelor's degree in a life science, engineering, or equivalent required. Advanced degree preferred.
- Six Sigma/Lean Black Belt certification, preferred.
- ASQ Certifications for Certified Quality Engineer, (CQE), Certified Supplier Quality Professional (CSQP) Risk Management Specialized credential, or Quality Manager (CQM) preferred.
- Eight (8) or more years of work experience in IVD or medical device industry required.
- Six (6) year of work experience in Quality Engineering in the designated specialty of Process Quality Engineering, Supplier Quality Engineering, Design Quality Engineering for laboratory instruments (hardware and software), Design Quality Engineering for medical software, Design Quality Engineering for IVD assay reagents, Design Quality Engineering for IVD system integration, Risk Quality Engineering, or related functions required.
Skills & Capabilities
- Advanced knowledge of current compliance requirements (e.g., US Quality System Regulations (QSRs), EU in vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, ISO 17025, IEC 60825 or other regulations and standards).
- Advanced knowledge in the following:
- All disciplines: design controls, risk assessment and analysis, root cause investigations, trend analysis, statistical sampling, change control assessment, nonconformance assessment, design of experiments, project management, and data mining.
- Process Quality Engineering: qualifications (equipment, facilities, and packaging and shipping), design transfer, process validation, and production and process controls (process capability, process optimization, gauge repeatability & reproducibility, and statistical process controls).
- Supplier Quality Engineering: integrated of contract supplier into design controls, quality planning, specifications, acceptance methods and criteria, and supplier change management.
- Design Quality Engineering for laboratory instruments (hardware, consumables, and software): mechanical and software engineering, cybersecurity for laboratory instrumentation, and IVD system integration
- Design Quality Engineering for IVD assay reagents: IVD functional principles for ELISA, IFA, CIA, and microspheres, material qualification, reagent stability and artificial intelligence applications.