Sr. Quality Engineer

Glaukos Corporation•Burlington, MA

22h•Hybrid

About The Position

The Sr. Quality Engineer works with Quality Engineering and other functional groups to develop, implement, and scale up products and processes for Class III medical devices. The role leads manufacturing process changes, product design improvements, new product implementation, quality improvements for legacy products, continuous improvement, and customer satisfaction initiatives. It supports transfer of new designs into production by assessing supplier process capabilities and qualifying parts, and provides technical oversight for product and process validations in collaboration with Product Development, Applied Research, Manufacturing, and vendors. The position prepares, performs, reviews, and approves technical documentation, including validation protocols and reports, test procedures and reports, equipment qualifications, and document change orders. It applies APQP and PPAP to develop production and design standards; establishes quality controls; resolves product-quality issues; and develops trend requirements for NCR, CAPA, and SPC processes covering incoming inspection, manufacturing processes, and vendors. The engineer evaluates data and uses statistical tools and Six Sigma methodology to support acceptance decisions and process improvement. The role also provides technical support in validation, statistics, biocompatibility, DFM, risk analysis, FMEA, root-cause analysis, testing, quality equipment, specifications, and vendor quality. It coordinates with suppliers to address nonconforming products and hazardous situations; conducts and maintains development-product risk analyses; and develops and manages equipment and facility requirements, including clean-room design, maintenance, and validation programs. The position supports regulatory and company compliance, initiates and investigates CAPAs, assists with complaint analysis, and trains and guides lower-level employees. Up to 10% local travel to contract manufacturing organizations in Massachusetts and New Hampshire is required. Hybrid remote work is permitted within Massachusetts.

Requirements

U.S. master's degree or equivalent in Industrial/Manufacturing Engineering or a related discipline.
Two years of experience in the job offered or as an Industrial, Manufacturing, Quality, or Supplier Development Engineer, or in a related occupation.
Experience with manufacturing process validation and GMP.
Experience using statistical tools, including standard deviation, control charts, Pareto charts, histograms, trend analysis, and Six Sigma methodology.
Experience with structured manufacturing frameworks, including APQP and PPAP.
Experience drafting standard quality requirements.
Experience with DFM, risk analysis, FMEA, and testing requirements and methods.
Experience with NCR, CAPA, and SPC processes.
Experience evaluating supplier technical capabilities.
Experience coordinating activities with internal departments and external vendors or suppliers.
Good written and oral communication skills.

Responsibilities

Work with Quality Engineering and other functional groups to develop, implement, and scale up new product and process development activities for Class III medical devices.
Lead manufacturing process changes, product design improvements, new product implementation, legacy-product quality improvements, continuous improvement, and customer satisfaction efforts.
Support transfer of new designs from development to production by assessing supplier process capabilities and qualifying parts.
Provide technical oversight for internal and external product and process validations in coordination with Product Development, Applied Research, Manufacturing, and vendors.
Write, perform, review, and approve validation protocols and reports, test procedures and reports, equipment qualifications, and document change orders.
Apply APQP and PPAP to develop production and design standards.
Develop effective quality controls and resolve product-quality issues.
Develop trend requirements and support NCR, CAPA, and SPC processes for incoming inspection, processes, and vendor operations.
Evaluate data, identify trends, and use statistical tools and Six Sigma methodology to make acceptance decisions and improve processes.
Provide technical support for validation requirements, statistics, biocompatibility assessment, DFM, risk analysis, FMEA, root-cause analysis, testing requirements and methods, quality equipment, specifications, and vendor quality.
Coordinate with suppliers and vendors to review and mitigate nonconforming products and hazardous situations.
Conduct, document, and maintain risk analyses for development products and comply with risk analysis, design control, and related procedures.
Develop and manage equipment and facility requirements, design, maintenance, and validation programs, including for clean rooms.
Ensure compliance with applicable federal, state, and local regulations, as well as company regulations, policies, and procedures.
Initiate and investigate CAPAs and assist with complaint analysis as appropriate.
Train, coach, and guide lower-level employees on routine procedures.
Travel locally up to 10% to contract manufacturing organizations in Massachusetts and New Hampshire.