Sr. Quality Engineer

Glaukos•Burlington, MA

23h•$89,000 - $111,300•Hybrid

About The Position

The Sr. Quality Engineer works with Quality Engineering and other functional groups to develop, implement, and scale up new product and process development activities for Class III medical devices. The role leads manufacturing process changes, product design improvements, new product implementation, quality improvement opportunities for legacy products, continuous improvement, and customer satisfaction initiatives. The engineer leads transfer of new designs from development to production, including supplier process capability assessments and part qualification. The position provides technical oversight for internal and external product and process validations and requirements, working with Product Development, Applied Research, Manufacturing, and vendors. It prepares, performs, reviews, and approves technical documents such as validation protocols, test procedures and reports, equipment qualifications, document change orders, and process and product validation documentation, applying APQP and PPAP to develop production and design standards. The role develops effective quality controls, resolves product quality issues, and develops trend requirements for NCR, CAPA, and SPC processes covering incoming inspection, manufacturing processes, and vendor operations. It evaluates data and uses statistical tools and Six Sigma methodology to support acceptance decisions and process improvement. Technical support includes validation requirements, statistics, biocompatibility assessment, DFM, risk analysis, FMEA, root cause analysis, testing requirements and methods, quality equipment, specifications, and vendor quality. The engineer coordinates with suppliers and vendors to review and mitigate nonconforming products and hazardous situations. The position conducts, documents, and maintains risk analyses for development products and complies with risk analysis, design control, and related procedures. It develops and manages equipment and facility requirements, design, maintenance, and validation programs, including clean rooms; ensures regulatory and company compliance; initiates and investigates CAPAs; assists with complaint analysis; and trains, coaches, 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.
At least 2 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 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 outside 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.
Lead 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 and requirements in collaboration with Product Development, Applied Research, Manufacturing, and vendors.
Write, perform, review, and/or 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 for NCR, CAPA, and SPC processes related to incoming inspection, manufacturing processes, and vendor operations.
Evaluate data and trends, use statistical tools and Six Sigma methodology to make acceptance decisions, and improve processes.
Provide technical support in validation, 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 clean rooms.
Ensure compliance with Federal, State, local, and company regulations, policies, and procedures.
Initiate and investigate Corrective and Preventative Actions (CAPA) 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.