Project Quality Engineer

The Project Quality Engineer provides project support to all scoped projects impacting quality assurance, continuous improvement and compliance of Laboratory Operations. Furthermore, this role focuses on establishing strategies for quality engineering, inspection & testing, suppliers and supply chain activities (including LIMS) and validations to achieve operational excellence.

The Project Quality Engineer will collaborate with cross functional representatives such as Laboratory Operations, Digital Pathology, Pathology Operations, Supply Chain, Facilities, to develop validation strategies, and industry best practices in the implementation of manufacturing operations in a clinical/CLIA/CAP/LDT laboratory environment.

Job Responsibilities:

General Duties

• Serve as the Company's Quality representative on all functional and enterprise-wide projects.
• Responsible for establishing the validation and ongoing quality assurance of products moving through the R&D pipeline. Meet regularly with key commercial and R&D and Operations leaders to assess product and technology directions and offer recommendations on validation strategies in alignment with regulatory considerations for US and EU.
• In collaboration with Regulatory and Quality leadership, represent the Company in interactions with regulatory authorities.
• Work with outside consultancies to establish a roadmap to compliance with the recent FDA LDT ruling and other projects that support the regulatory evolution of the Company.
• Collaborate regularly with the Company's head of quality on all laboratory quality requirements, quality manual, quality system, and compliance with laboratory-specific agencies including CLIA and CAP. Work together to achieve appropriate ISO certifications.
• Independently manage and monitor multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas without direct supervision. Maintain a "focused urgency" as required by specific events.
• Work closely with the quality team to maintain all necessary documents in an effective manner.
• Other duties as assigned.

Sustaining Laboratory Operation Projects

• Work closely with laboratory/manufacturing operations and other functions to ensure quality performance of product workflows and associated processes.
• Support process development and process validation for the laboratory operations.
• Establish process quality metrics and monitor laboratory processes, identifying potential failure modes, risks, controls, and opportunities for improvement while leading large scope CAPA.
• Utilizing statistical analysis and six sigma techniques, drive product/process improvements and set the foundation for operational excellence.
• Lead the quality processes within enterprise-wide projects (i.e. LIMS) to ensure validation and regulatory requirements are met.
• Lead the equipment commissioning, qualification and risk management process.

New Product Introduction (NPI)

• Develop quality engineering processes within the NPI process to promote quality assurance during the technology transfer process.
• Utilize risk assessments such as Failure Modes and Effects Analysis (FMEA) to identify and address potential product and process risks throughout the development and NPI process.
• Lead the validation strategy development for products being transferred.

Supplier Quality

• Oversee supplier quality initiatives, including supplier selection, monitoring of supplier performance, conducting audits, and ensuring effective corrective actions to maintain a robust supplier quality program.
• Support the development of material specification and incoming inspection process including test method development and test method validation.
• Lead the risk-based product/process validation strategy for all supply chain projects that impact product, equipment and process.

Knowledge, Skills & Experience:

• 7+ years in Quality Assurance or related functional area preferably in the IVD or medical device manufacturing environment or CLIA/CAP/LDT/clinical laboratory operations.
• Development and implementation of production and process controls (i.e. PDCA, DMAIC experience).
• Demonstrated knowledge of improvement and statistical tools/techniques used within process excellence activities.
• Experience in executing problem-solving techniques related to manufacturing/design technical issues.
• Proven ability to drive and develop improvement of critical business metrics.
• Direct responsibility for process development, design transfer or continuous improvement projects within the quality engineering function.
• Knowledge of ISO 13485 and ISO 14971, FDA Quality System Regulation 21 CFR Part 820 or CGMP preferred.
• Experience in the development of risk management processes preferred.

Education, Certifications & Licensures:

• B.S. in Engineering, engineering related discipline or equivalent experience.
• ASQ-CQE, CQA experience preferred.
• Six Sigma Black Belt Certification preferred.

Special Training:

• Fulfill the Company's manager training related to the Company's products, scientific foundation, and other areas.

Physical Demands:

• Ability to use copiers, fax machines, and PDF scanners to keep inventory and ordering records. Visual acuity and analytical skill to distinguish sufficient detail.
• Must possess the ability to sit or stand for long periods.
• Must possess the ability to perform repetitive motion.
• May have exposure to biohazardous material in the lab environment.