Sr. Quality Engineer

Glaukos Corporation; Burlington (AL); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Glaukos Corporation, a leader in ophthalmic medical devices, seeks a Quality/Manufacturing Process Engineer to drive the design, development and scale-up of new products and process changes. You will lead validations, control plans, and supplier evaluations to ensure quality and regulatory compliance across development and production teams.

The role requires expertise in GMP, APQP/PPAP, risk analysis, and data-driven quality improvement, with collaboration across Product Development, Applied

Qualifications

• Master's degree in Industrial/Manufacturing Engineering or related field.
• 2 years of relevant experience in industrial/manufacturing/quality/supplier development engineering or related occupation.
• Proficiency with manufacturing validation and GMP practices.
• Experience with APQP/PPAP and quality system tools.

Responsibilities

• Lead design, development, and review of manufacturing process changes and product design improvements to scale up new products.
• Provide technical oversight for validation protocols, test procedures, and reports; ensure compliance with risk analyses and design controls.
• Coordinate with Product Development, Applied Research, Manufacturing and vendors to transfer designs from development to production.
• Develop and manage equipment/ facility requirements, including clean room validation and qualification programs.
• Initiate and drive CAPA investigations and support complaint analysis and data trend review.

Skills

Manufacturing validation

GMP experience

APQP

PPAP

DFM

Risk analysis

FMEA

NCR/CAPA/SPC

Supplier evaluation

Excellent communication

Education

Master's degree in Industrial/Manufacturing Engineering

Job description

JOB DUTIES

Work with Quality Engineering and other functional groups to develop, implement and scale up new products/process development activities of Class III medical devices. Lead the design, development and review of manufacturing process changes, product design improvements and the implementation of new products efforts with quality improvement opportunities for legacy products, continuous improvement, and customer satisfaction. Lead efficient transfer of new design from development to production by assessing supplier’s process capabilities and part qualification. Provide technical oversight in defining and conducting internal/external product and process validations and requirements, working closely with Product Development, Applied Research, and Manufacturing personnel as well as vendors. Write, perform, and/or review technical documents such as Validation Protocols, Test Procedures, and Test Reports. Write, review and/or approve process and product validation protocols and reports, equipment qualifications, document change orders applying APQP & PPAP to develop production and design standards. Develop and establish effective quality control and resolve product quality issues. Develop trend requirements to support the QA/QC department in the following areas: NCR, CAPA, and SPC processes for incoming inspection, process, and vendor operations. Evaluate data and identify trends in order to develop innovative solutions. Use statistical tools, such as Standard deviation, Control charts, Pareto charts, Histograms, Trend analysis, and Six sigma methodology, to analyze data, make acceptance decisions, and improve process. Provide technical support in areas including validation requirements, statistics, biocompatibility assessment, DFM, risk analysis, FMEA, root cause analysis, testing requirements and methods, quality equipment, specifications, vendor quality, among others, and coordinate with suppliers/vendors to review and mitigate any non-conformance product and hazardous situation. Conduct, document, and maintain risk analyses for all development products and comply with risk analysis, design control, and any other related procedures. Develop and manage equipment and facility (including clean room) requirements, design, maintenance, and validation programs. Ensure compliance with all Federal, State, local and company regulations, policies, and procedures. Initiate and investigate Corrective and Preventative Actions (CAPA) and assist in complaint analysis as appropriate. Train, coach, and guide lower-level employees on routine procedures.

*Up to 10% local travel to CMOs (Contract Manufacturing Organizations) in Massachusetts and New Hampshire.

Hybrid Remote permitted within Massachusetts.

JOB REQUIREMENTS

1. U.S. Master's degree or equivalent in Industrial/Manufacturing Engineering, or related discipline, plus 2 years in job offered or as Industrial / Manufacturing / Quality / Supplier Development Engineer or related occupation.

2. Must include experience with the following:

• Manufacturing process validation and GMP;
• Statistical tools: Standard deviation, Control charts, Pareto charts, Histograms, Trend analysis, and Six sigma methodology;
• Structured manufacturing frameworks, including APQP & PPAP;
• Drafting standard quality requirements;
• DFM, risk analysis, FMEA, testing requirements and methods;
• NCR, CAPA, and SPC processes;
• Evaluating supplier technical capabilities;
• Coordinating activities with internal departments and outside vendors/suppliers.

3. Good written/oral communication skills.

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.

Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.